[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,393,0,25,[9,46,70,98,123,156,177,197,224,256,288,316,342,368,391,414,472,494,524,550,585,610,636,658,681],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596033","gustabor-phase-1---ai-based-creation-of-a-nutritional-plan-to-compensate-for-chemotherapy-induced-taste-disorders-100596033",false,"NCT07040189","Gustabor Phase 1 - AI-based Creation of a Nutritional Plan to Compensate for Chemotherapy-induced Taste Disorders","GustaborPilot","Inclusion Criteria:\n\n* Age ≥ 18\n* Suffering from one of the following tumor entities: Multiple myeloma or malignant tumor of the gastrointestinal tract\n* Mainly oral nutrition\n* Subjectively perceived tumor therapy-related taste disorder\n* At least two clinical presentations planned within 12 weeks with a minimum interval of three weeks\n* Ability to participate in nutritional intervention, including use of the online portal and implementation of recipe suggestions (e.g. resources and access to a kitchen), either independently or with third-party support (e.g. by relatives, outpatient care services).\n\nExclusion Criteria:\n\n* Pregnancy\n* Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)\n* Placement in an inpatient care facility","ALL","18 Years",{"count":20,"type":21},51,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study investigates taste disorders that commonly occur during or after cancer treatment, often leading to issues such as malnutrition and treatment discontinuation. Although many non-pharmacological recommendations exist, it is unclear which methods are suitable for which individuals. This pilot study aims to use an AI-based, or rule-driven system to generate personalized recommendations based on patients' specific impairments and taste disorder. For the pilot study, the AI will be trained on recipes to create individualized meal plans, helping to identify foods that are likely to be better. The primary endpoint is the assessment of the nutritional intervention as helpful at the second visit within 12 weeks of inclusion.",[27,28,29],"Multiple Myeloma","GI Cancer","Taste Disorders",[31,32],"taste disorders","AI","RECRUITING","2026-08-19",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":37},"2025-11-25",{"date":41,"type":21},"2026-12-31",{"name":43,"class":44},"Wuerzburg University Hospital","OTHER",3,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100432396","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-activity-of-cevostamab-in-participants-with-relapsed-or-refractory-multiple-myeloma-100432396","NCT04910568","A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma","An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","CAMMA 1","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Life expectancy of at least 12 weeks\n* Agreement to provide bone marrow biopsy and aspirate samples\n* Resolution of adverse events from prior anti-cancer therapy to Grade \\\u003C=1\n* Measurable disease\n* For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered\n* For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria\n* Diagnosis of R\u002FR MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria\n* For Cohort B1S: Participants with R\u002FR MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)\n* For Cohort B2S, B1E, B3E: Participants with R\u002FR MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD\n* For Cohort B4E: Participants with R\u002FR MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy\n* Agreement to comply with all requirements of the pomalidomide pregnancy prevention program\n* For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered\n* For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria\n* For Cohort C1S: Patients with R\u002FR MM who have received at least two prior lines of treatment including a PI and an IMiD\n* For Cohort C2S and additional cohorts: Participants with R\u002FR MM who have received at least 1 prior line of therapy\n* For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered\n* For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period\n\nExclusion Criteria:\n\n* Prior treatment with cevostamab or another agent targeting FcRH5\n* Inability to comply with protocol-mandated hospitalization and activities restrictions\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the last dose of cevostamab or within 3 months after the last dose of tocilizumab (if applicable).\n* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drugconjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy\n* Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment\n* Prior treatment with CAR T-cell therapy within 12 weeks before first study treatment\n* Treatment with radiotherapy within 4 weeks (systemic radiation) or 14 days (focal radiation) prior to first study treatment\n* Treatment with any chemotherapeutic agent or other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first study treatment\n* Autologous SCT within 100 days prior to first study treatment\n* Prior allogeneic stem cell transplant(ation) (SCT)\n* Circulating plasma cell count exceeding 500\u002Fmicro L or 5% of the peripheral blood white cells\n* Prior solid organ transplantation\n* History of autoimmune disease\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Known history of amyloidosis\n* Lesions in proximity of vital organs that may develop sudden decompensation\u002Fdeterioration in the setting of a tumor flare\n* History of other malignancy within 2 years prior to screening\n* Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM\n* Significant cardiovascular disease\n* Symptomatic active pulmonary disease or requiring supplemental oxygen\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Recent major surgery within 4 weeks prior to first study treatment\n* Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection\n* Acute or chronic hepatitis C virus (HCV) infection\n* Known history of Grade \\>= 3 CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior bispecific therapies\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or immune effector cell associated hemophagocytic lymphohistiocytosis like syndrome (IEC HS)\n* Active symptomatic coronavirus disease 2019 (COVID-19) infection at study enrollment or requiring treatment with intravenous (IV) antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Patients with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment\n* Positive and quantifiable EBV polymerase chain reaction (PCR) or Cytomegalovirus (CMV) PCR prior to first study treatment\n* Known history of HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study\n* Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment \\\u003C=10 mg\u002Fday prednisone or equivalent, within 2 weeks prior to first study treatment\n* History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment Additional Arm B-Specific Exclusion Criteria\n* Pregnant or breastfeeding, or intending to become pregnant 4 weeks prior to initiation of study treatment, during the study, (including treatment interruptions) or within 4 weeks after the last dose of pomalidomide\n* Significant cardiovascular disease (such as, but not limited to, New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 12 months, uncontrolled arrhythmias, or unstable angina)\n* History of erythema multiforme, Grade \\>=3 rash, blistering, or severe hypersensitivity to prior treatment with immunomodulatory drugs such as thalidomide, lenalidomide, or pomalidomide\n* Inability to tolerate thromboprophylaxis, or contraindication to thromboprophylaxis\n* GI disease that might significantly alter absorption of oral drugs Additional Arm C-Specific Exclusion Criteria\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 102 days after the last dose of daratumumab\n* Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of daratumumab formulations\n* Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal\n* Known moderate or severe persistent asthma within the past 2 years, or current uncontrolled asthma of any classification",{"count":55,"type":21},186,[57],"PHASE1","This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R\u002FR MM) via intravenous (IV) infusion.",[27],{"date":61,"type":37},"2026-08-20",{"date":63,"type":37},"2021-07-26",{"date":65,"type":21},"2028-12-21",{"name":67,"class":68},"Genentech, Inc.","INDUSTRY",34,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100524301","phase-1-azd0305-as-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-multiple-myeloma-100524301","NCT06106945","AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma","A Modular Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma","Key Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction\n* in which the study is taking place;\n* Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;\n* Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria;\n* Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;\n* Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;\n* Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy\n\nThe above is a summary of key criteria, other inclusion criteria details may apply\n\nKey Exclusion Criteria:\n\n* Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);\n* Participants exhibiting clinical signs of central nervous system involvement of MM;\n* Participants with known COPD, or previous history of ILD\u002Fpneumonitis;\n* Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;\n* Participants who have severe cardiovascular disease which is not adequately controlled;\n* Participants who have a history of immunodeficiency disease;\n* Participants with peripheral neuropathy ≥ Grade 2;\n* Primary refractory MM;\n* Participants who have previously received anti-GPRC5D or MMAE-containing treatment;\n* Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention;\n* Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;\n* Participants with previous history of active JC virus infection resulting in PML;\n* Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;\n* Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and\u002For other administration\n\nThe above is a summary of key criteria, other exclusion criteria details may apply",{"count":78,"type":21},226,[57,80],"PHASE2","This is a Phase I\u002FII, modular, open-label, multicenter, dose escalation, and dose expansion\u002Foptimization study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics and efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.",[27],[84,85,86,27,87,88],"GPRC5D","ADC","AZD0305","MM","MMAE","2026-08-18",{"date":34,"type":37},{"date":92,"type":37},"2023-12-05",{"date":94,"type":21},"2027-08-16",{"name":96,"class":68},"AstraZeneca",43,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100494181","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-belantamab-for-the-treatment-of-multiple-myeloma-when-used-as-monotherapy-and-in-combination-treatments-100494181","NCT05714839","A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments","A Phase 1\u002F2 Open-label, Multicentre, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, and Clinical Activity of Belantamab as Monotherapy and in Combination With Other Treatments in Participants With Multiple Myeloma","DynaMMic-1","Inclusion criteria\n\n* Participants at the time of signing the Informed Consent Form (ICF) are at least 18 years old or are of the legal age of consent in the jurisdiction in which the study is taking place.\n* Participants who have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the international myeloma working group (IMWG) and have progressed on or following the last line of treatment\n\n  * Part 1 and Part 2: Participants who have received at least 3 prior lines of anti-myeloma treatments, including any immunomodulatory drug (IMiDs lenalidomide, pomalidomide or thalidomide), a proteasome inhibitor, and an anti-CD38 monoclonal antibodies (mAb) (either in combination or separately).\n  * Part 3: Have received at least 1 prior line of treatment anti-myeloma treatments, including lenalidomide. Prior anti-CD38-containing regimen is not mandated, however no more than 70% of participants recruited may be anti-CD38 naïve.\n* Participants with a history of Autologous stem cell transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  * transplant was greater than (\\>)100 days prior to screening.\n  * No active bacterial, viral, or fungal infection(s) present\n* Eastern cooperative oncology group-performance status (ECOG-PS) of 0 to 2.\n* Measurable disease defined as at least ONE of the following:\n\n  * Serum M-protein concentration greater than or equal to (\\>=) 0.5 gram (g)\u002F deciliter (dL) (\\>=5 gram\u002Fliter \\[g\u002FL\\])\n  * Urine M-protein excretion \\>=200 milligram (mg)\u002F24 hours (\\>=0.2 g\u002F24 hours)\n  * Serum free light chain (FLC) assay: involved FLC level \\>=10 mg\u002FdL (\\>=100 milligrams per liter \\[mg\u002FL\\]) and an abnormal serum FLC ratio (less than \\[\\\u003C\\]0.26 or \\>1.65)\n* Have adequate organ system function as defined by the laboratory assessments\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \\[NCI-CTCAE\\], v5.0, 2017) must be Grade less than or equal to (\\\u003C=)1 at the time of screening except for alopecia (any grade), neuropathy (Grade \\\u003C=2), or endocrinopathy managed with replacement therapy (any grade).\n* Participants or legally authorized representative (LAR) (if applicable per local regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Male Participants (for parts 1b, 2 and 3):\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male Participants enrolled in part 1 (and expansion) cohort receiving belantamab monotherapy are not required to use contraception\n* Male participants are eligible to participate in parts 2 and 3 if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:\n\n  * Refrain from donating fresh unwashed semen PLUS either:\n\n    * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n    * Must agree to use contraception\u002Fbarrier as detailed below\n    * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1 percent (%) per year when having sexual intercourse with POCBP who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is NOT a Participant of child-bearing potential (POCBP) or\n  * Is a POCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, 30 days prior to treatment start, during the intervention period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n* Part 3: Due to pomalidomide being a thalidomide analogue with a risk for embryofetal toxicity and prescribed under a pregnancy prevention\u002Fcontrolled distribution program, POCBP will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or use two methods of reliable birth control (one method that is highly effective plus an additional barrier method), beginning at least 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Thereafter, POCBP must use one contraceptive method that is highly effective (with a failure rate of less than (\\\u003C)1% per year) for a further 3 months (total 4 months).\n* The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention\n* All POCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.\n\nExclusion criteria\n\n* Diagnosis of primary Amyloid Light chain (AL) Amyloidosis, active Polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes (POEMS) syndrome, primary plasma cell leukemia.\n* Part 3: Active or history of venous or arterial thromboembolism within the past 3 months. Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis\n* Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.\n* Participant is exhibiting signs of meningeal or central nervous system involvement with MM.\n* Part 2: Current corneal epithelial disease except nonconfluent Superficial punctate keratitis (SPK).\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal\u002Fgastric varices, or persistent jaundice.\n* Presence of malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the Principal investigator (PI) and GlaxoSmithKline (GSK) Medical Director, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants on active surveillance or hormone treatment for non-metastatic prostate cancer are not excluded. Participants on hormone therapy for non-metastatic breast cancer are not excluded\n* Evidence of cardiovascular risk including any of the following:\n\n  * Evidence of current clinically significant untreated arrhythmias, including, but not limited to, clinically significant Electrocardiogram (ECG) abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree Atrioventricular (AV) block.\n  * Part 1 dose escalation and Part 2 only: QT interval corrected using Fridericia's formula (QTcF) interval \\>480 millisecond (msec) (QT interval corrected for heart rate according to Fridericia's formula), and\u002For hypokalemia, and\u002For family history of long QT syndrome.\n  * Part 1 dose expansion and Part 3: Not applicable.\n  * History of MI, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting or bypass grafting, all within three months of screening.\n  * Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n  * Uncontrolled hypertension\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab \u002F belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other Monoclonal antibodies (mAbs).\n* Active infection requiring antibiotic, antiviral, or antifungal treatment.\n* For serology of Hepatitis B surface antigen (HBsAg)+ at screen or within 3 months prior to first dose Japan only: must test Hepatitis B e antigen (HBeAg) and Hepatitis B e antibody (HBeAb). Eligibility verification should be evaluated and agreed with a hepatologist (after they record the approval in the participant medical record).\n* Known Human immunodeficiency virus (HIV) infection, unless the participant can meet specific criteria.\n* Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n* Participants with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) will be excluded unless specific criteria can be met.\n* Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible.\n* Part 1: Refractory to belantamab mafodotin (confirmed PD as per IMWG criteria while on belantamab mafodotin therapy or within 60 days of completing that treatment). Prior belantamab mafodotin is allowed if it was discontinued due to toxicity which subsequently resolved. Note: Prior treatment with other anti- B-cell maturation antigen (BCMA) directed agents is allowed. Provided there is at least 6-month washout after the last dose of prior anti-BCMA therapy.\n* Part 2: Prior belantamab mafodotin therapy is not allowed. Prior treatment with other anti-BCMA directed agents is allowed provided there is at least a 6-month washout after the last dose of prior anti-BCMA therapy .\n* Prior radiotherapy within 2 weeks of start of study therapy.\n* Plasmapheresis within 7 days prior to the first dose of study drug.\n* Prior allogeneic stem cells transplant.\n* Participants who have received prior Chimeric Antigen Receptor T-cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.\n* Any major surgery (other than bone-stabilizing surgery) within 2 weeks of first dose or has not recovered fully from surgery.\n* Prior treatment with a mAb within 30 days of receiving the first dose of study drugs, or treatment with an investigational agent or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is longer.\n* Part 1 dose escalation only: Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including Granulocyte colony stimulating factor \\[G-CSF\\], Granulocyte-macrophage colony-stimulating factor \\[GMCSF\\], recombinant erythropoietin) or any thrombopoietin receptor agonists within 2 weeks before the first dose of study drug. This does not apply for Part 1 Expansion Cohort.\n* Part 3: Prior belantamab, belantamab mafodotin, and pomalidomide therapy are not allowed. Prior treatment with other anti- BCMA directed agents is allowed provided there is at least 6-month washout after the last dose of prior anti-BCMA therapy.\n* Participants must not receive live\u002Flive attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab for at least 70 days following last study treatment.\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective Independent Review Board (IRB) approval (by chair or designee) is allowing exception to this criterion for a specific participant.\n* The use of other anti-cancer therapy not specified in this protocol, and any investigational agents other than belantamab and belantamab mafodotin, or any other MM Standard of Care (SoC) agents other than pomalidomide or dexamethasone are explicitly prohibited for the duration of the study.",{"count":107,"type":21},123,[57,80],"The study consists of three parts:\n\n* Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+).\n* Part 2: The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of belantamab in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+).\n* Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the belantamab in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.",[27],[112,113,114],"Belantamab","Belantamab Mafodotin","Relapsed or Refractory Multiple Myeloma",{"date":34,"type":37},{"date":117,"type":37},"2023-06-14",{"date":119,"type":21},"2028-08-03",{"name":121,"class":68},"GlaxoSmithKline",44,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":139,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100652655","monitoring-for-cardiotoxicity-using-wearable-devices-while-undergoing-cancer-treatments-mct-wave-100652655","NCT07776964","Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)","Inclusion Criteria:\n\n* Diagnosis of breast cancer, hematologic malignancy including leukemia or lymphoma, or multiple myeloma\n* At least 18 years of age\n* Capable of understanding and willing to sign a consent form for this study\n\nExclusion Criteria:\n\n* Known allergy to adhesive patches used for ambulatory EKG monitoring\n* Children\n* Cognitively challenged individuals\n* Prisoners\n* Active service military personnel",{"count":130,"type":21},72,[24],"This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.\n\nParticipants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers.\n\nParticipants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.",[134,135,136,137,138,27],"Cardiotoxicity","Cancer","Cardiac Arrhythmia","Left Ventricular Dysfunction","Breast Cancer",[140,141,142,143,144,145],"MCT-WAVE","Mobile cardiac telemetry","Wearable cardiac monitor","Cardio-oncology","Ventricular arrhythmia","Breast cancer","NOT_YET_RECRUITING","2026-08-17",{"date":61,"type":37},{"date":150,"type":21},"2026-09-01",{"date":152,"type":21},"2028-09-01",{"name":154,"class":44},"University of Minnesota",1,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":155},"100630282","phase-2-identifying-effective-and-cost-conscious-maintenance-daratumumab-dosing-100630282","NCT07485647","Identifying Effective and Cost-Conscious Maintenance Daratumumab Dosing","Inclusion Criteria:\n\n* Signed and dated written informed consent\n* Male or female newly diagnosed multiple myeloma (NDMM) patients 18 to 70 years old on the day of signing informed consent who had ASCT with post-ASCT response of partial response (PR) or better as defined by International Myeloma Working Group (IMWG). The induction regimen should include a proteasome inhibitors (PI), immunomodulatory drugs (IMiD) and anti-CD38 monoclonal antibody\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patients with high-risk and international staging system (ISS) stage-III disease in 15% of the intent to treat population. Patients with 1q gain, 1p deletion, del17p, t\\[4;14\\], or t\\[14;16\\] by fluorescence in situ hybridization \\[FISH\\] will be categorized as having high risk disease\n* Absolute neutrophil count, ≥ 1.0 × 10\\^9\u002FL\n* Platelets ≥ 75,000\u002FμL\n* Hemoglobin level ≥ 7.5 g\u002FdL\n* Total bilirubin \\\u003C 1.5 times institutional upper limit of normal (ULN) (if patient has known history of Gilbert's syndrome, total bilirubin will not be used as an exclusion criteria)\n* Corrected serum calcium, ≤ 14.0 mg\u002FdL (≤ 3.5 mmol\u002FL)\n* Platelet count, ≥ 50 × 10\\^9\u002FL (≥ 50 × 10\\^9\u002FL if ≥ 50% of the bone marrow was infiltrated with multiple myeloma \\[MM\\] cells)\n* Alanine aminotransferase and aspartate aminotransferase levels \\\u003C 2.5 times the upper limit of normal\n* Creatinine clearance ≥ 30 mL\u002Fmin (per institutional standard)\n* All ASCT-related toxicities must have recovered to ≤ grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization\n* Mucositis and gastrointestinal symptoms must have resolved to ≤ grade 1\n* Patients must not be pregnant due to potential harm to the fetus from daratumumab and lenalidomide. All patients of childbearing potential must have a negative test result via blood test or urine study with a sensitivity of at least 50 mIU\u002FmL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. Patients of childbearing potential must also agree to ongoing pregnancy testing while on treatment. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: \\* 1) has achieved menarche at some point, \\* 2) has not undergone a hysterectomy or bilateral oophorectomy, or \\* 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Patients of childbearing potential must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for \\* 1) at least 28 days before starting study treatment; \\* 2) while participating in the study; \\* 3) during dose interruptions; and \\* 4) for at least 3 months after the last dose of protocol treatment. Patients must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a partner of childbearing potential while participating in the study and for 3 months after the last dose of lenalidomide even if they have had a successful vasectomy. Patients must also agree to abstain from donating sperm, even if they have had a successful vasectomy, or eggs while on study treatment and for 3 months after the last dose of protocol. Patients must agree to abstain from donating blood during study participation and for at least 28 days after last dose of lenalidomide\n\nExclusion Criteria:\n\n* All patients with concomitant amyloidosis or plasma cell leukemia\n* Patient is pregnant or breastfeeding\n* Has received a live vaccine within 30 days prior to first dose of study treatment. \\* Examples of prohibited live vaccines include but are not limited to: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guérin (BCG), and typhoid vaccine. \\* Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (for example FluMist® Quadrivalent \\[Influenza Vaccine Live, Intranasal, MedImmune\\]) are live attenuated vaccines and are not allowed. COVID-19 vaccines that are messenger ribonucleic acid (mRNA) based which do not use live virus are allowed\n* Is currently participating in or within 4 weeks prior to receiving first dose of study treatment in a study of an investigational agent or investigational device. \\* Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose or last exposure to the previous investigational agent or investigational device\n* Diagnosis of immunodeficiency; or is receiving systemic steroid therapy exceeding 10 mg daily prednisone equivalent dose (=10mg is acceptable); or has received any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to first dose of study treatment. \\* Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (for example, in situ cervical cancer or breast carcinoma, superficial bladder cancer, or carcinoma in situ of the prostate) that have undergone potentially curative therapy are not excluded\n* Radiographically detectable (even if asymptomatic and\u002For previously treated) central nervous system metastases and\u002For carcinomatous meningitis as assessed by local site investigator and radiology review\n* Recipient of previous allogeneic tissue\u002Fsolid organ transplant\n* Known severe hypersensitivity (≥ grade 3) to drug daratumumab or lenalidomide\n* History of myocarditis or pericarditis or other known underlying heart disease that is clinically significant by investigator judgment (for example, cardiomyopathy, congestive heart failure with New York Heart Association \\[NYHA\\] functional classification III or IV, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction). History of cerebrovascular accident (including transient ischemic attack \\[TIA\\]) within the past 6 months (24 weeks) prior to starting study treatment\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection\u002Fsepsis, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Active autoimmune disease with immunodeficiency as a clinical component (for example, rheumatoid arthritis, systemic lupus erythematosus \\[SLE\\], ulcerative colitis, Crohn's disease, multiple sclerosis \\[MS\\], ankylosing spondylitis)\n* Recognized immunodeficiency disease including cellular immunodeficiencies; hypogammaglobulinemia or dysgammaglobulinemia; or acquired, hereditary, or congenital immunodeficiencies\n* Known conditions associated with immunosuppression such as uncontrolled HIV\u002FAIDS, leukemia, lymphoma, generalized malignancy, solid organ transplant recipient, or allogeneic hematopoietic stem cell transplant recipient\n* Gastrointestinal disease that may significantly alter the absorption of oral drugs\n* Unable or unwilling to undergo antithrombotic prophylactic treatment","70 Years",{"count":164,"type":21},50,[80],"This phase II trial tests daratumumab given at a reduced frequency with lenalidomide for maintenance therapy for the cost effective treatment of patients with multiple myeloma post stem cell transplant. Darzalex Faspor (also known as Daratumumab-hyaluronidase) is a combination of two drugs used alone or with other drugs to treat adults with certain types of multiple myeloma or light chain amyloidosis. Daratumumab binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Hyaluronidase allows daratumumab to be given by injection under the skin. Daratumumab and hyaluronidase can be given in less time than daratumumab alone, which is given as an infusion. Lenalidomide may stop or slow cancer cells by blocking the growth of new blood vessels necessary for tumor growth. Daratumumab-hyaluronidase is typically given every 4 weeks per standard of care. Giving it every 8 weeks for the first year followed by every 16 weeks for years 2 through 4 in combination with lenalidomide may be equally as effective and reduce costs and treatment visits for patients with multiple myeloma post stem cell transplant.",[27],[169],"ASCT",{"date":34,"type":37},{"date":172,"type":37},"2026-04-20",{"date":174,"type":21},"2029-04",{"name":176,"class":44},"Eden Biltibo",{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":155},"100545025","phase-2-immunoplant-for-newly-diagnosed-multiple-myeloma-100545025","NCT06376526","IMMUNOPLANT for Newly Diagnosed Multiple Myeloma","Immuno-consolidation for Newly Diagnosed Multiple Myeloma Using Lack of MRD Negativity After Initial cOmbination Therapy to Pursue Deeper Responses With Linvoseltamab ANd Delay Transplant","IMMUNOPLANT","Inclusion Criteria:\n\n1. Diagnosis of newly-diagnosed multiple myeloma (NDMM) per International Myeloma Working Group (IMWG) criteria documented initially prior to induction treatment.\n2. Documentation of having received a triplet or quadruplet based initial combination therapy containing at least two of the following: Immunomodulatory drug (IMiD), proteosome inhibitor (PI), and\u002For anti-cluster of differentiation 38 (anti-CD38).\n3. Documentation of attaining a best response of partial response (PR) or better but MRD+ (sensitivity: ≤10\\^-5) after at least 4 cycles of combination therapy.\n\n   Note: Patients who at baseline prior to initial combination therapy did not have IMWG evaluable disease and therefore a response assessment of VGPR was unable to be made but currently have residual MM by M-protein and\u002For involved light chains and\u002For MRD positivity may enroll. Also, patients who have no apparent bone marrow (BM) residual disease but rather extramedullary disease as evidenced by positron emission tomography (PET)\u002Fcomputed tomography (CT) may enroll.\n4. Age ≥18 years.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg, pain) may be allowed after discussion with the PI (APPENDIX A).\n6. Adequate organ function, which is defined as follows:\n\n   * a. Absolute neutrophil count (ANC) ≥1,000 cells\u002Fmicroliter (mcL) (unless patient has ethnic\u002Fcyclic neutropenia or if neutropenia is thought to be due to MM)\n   * b. Platelets ≥50,000 platelets\u002FmcL\n   * c. Hemoglobin ≥8 g\u002FdL (transfusions permitted)\n   * d. Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) or direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of \\\u003C3 X ULN)\n   * e. Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) ≤ 2.5 X ULN\n   * f. Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 (note that measured glomerular filtration rate \\[GFR\\], ie, 24-hour urine, can also be used) based on institutional standard\n   * g. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 6 months following the last dose of study treatment. For more information on contraception requirements, please refer to Section 4.11.\n   * h. Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. For more information on the informed consent process, please refer to Section 15.1.\n7. Willing and able to comply with clinic visits and study-related procedures.\n\nExclusion Criteria:\n\n1. Patients who have received prior systemic therapies for MM other than initial IMiD\u002FPI\u002Fanti-CD38-based combination therapy (receiving limited cycles of other induction therapies, eg, cyclophosphamide, bortezomib and dexamethasone (CyBorD) or pulse dexamethasone prior to main induction is allowed). Exclusions include high-dose melphalan with autologous stem cell transplant (HDM-ASCT) and allogeneic stem cell transplant (SCT).\n\n   Note: Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug is not permitted.\n2. Patients who are receiving any other investigational agents for any reasons.\n3. Patients who receive a live attenuated vaccine within 4 weeks of scheduled study treatment administration.\n4. Contraindication to any concomitant medication, including those medications administered for infusion reaction, antiviral, antibacterial, anticoagulation, tumor lysis, or hydration prophylaxis given prior to therapy (Sections 4.8, 4.9, and 7).\n5. Patient has any of the following:\n\n   1. Human immunodeficiency virus (HIV)-positive with 1 or more of the following:\n\n      * i. History of acquired immune deficiency syndrome (AIDS)-defining conditions cluster of differentiation 4 (CD4) count \\\u003C350 cells\u002Fmm3\n      * ii. Detectable viral load during screening or within 6 months prior to screening\n      * iii. Not receiving highly active anti-retroviral therapy\n      * iv. Had a change in anti-retroviral therapy within 6 months of the start of screening\n      * v. Receiving anti-retroviral therapy that may interfere with study treatment as assessed after discussion with the Sponsor-Investigator in consultation with study pharmacist\n   2. Hepatitis B infection (ie, hepatitis B surface antigen (HBsAg) or hepatitis B virus (HBV)-deoxyribonucleic acid \\[DNA\\] positive). Patients with resolved infection (ie, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and\u002For antibodies to hepatitis B surface antigen (anti-HBs)) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded. In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.\n   3. Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-ribonucleic acid (RNA) testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the experimental agents used in study.\n7. Female patient refuses to discontinue breastfeeding her infant during study treatment or within 6 months after receiving the last dose of study treatment (Section 4.11).\n8. Women of childbearing potential (WOCBP) and men who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose.\n\n   * Highly effective contraceptive measures for women include: stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening intrauterine device (IUD); intrauterine hormone-releasing system (IUS) bilateral tubal ligation vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the study participant and that the partner has obtained medical assessment of surgical success for the procedure) and\u002For sexual abstinence.\n   * WOCBP are defined as women who are fertile following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a post-menopausal state.\n   * Male study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. Male study participants should not donate sperm during the study, and for at least 6 months after the last dose. Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n   * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.\n\n   Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together (Section 4.11).\n9. Presence of the following cardiac conditions:\n\n   * e. New York Heart Association stage III or IV congestive heart failure\n   * f. Myocardial infarction or coronary artery bypass graft ≤ 6 months prior to study enrollment\n   * g. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities\n   * h. Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina)\n10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, venous thromboembolic disease, hemorrhage, pulmonary fibrosis, pneumonitis, neurological condition, active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing, or psychiatric illness\u002Fsocial situations within 2 weeks that would limit compliance with study requirements.\n11. Active malignancy other than MM requiring treatment in the past 12 months. Malignancies treated within the past 12 months that are considered cured with minimal risk of recurrence are allowed.\n12. Have any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.\n13. Patients with impaired decision-making capacity will not be enrolled on this trial.",{"count":186,"type":21},150,[80],"The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.",[27],{"date":89,"type":37},{"date":192,"type":37},"2024-08-21",{"date":194,"type":21},"2029-08-31",{"name":196,"class":44},"Dickran Kazandjian, MD",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":155},"100431492","improving-cognitive-function-in-older-adults-undergoing-stem-cell-transplant-100431492","NCT04898790","Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant","Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation","PROACTIVE","Arm 1:\n\nInclusion Criteria for Participants:\n\n* age 60 years and older\n* have a diagnosis of hematological malignancy\n* have received autologous or allogeneic HCT within the prior 3-6 months\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Participants' Care-Partner:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria\n\nArms 2 and 3:\n\nInclusion Criteria for Participants:\n\n* age 55 years and older\n* have a diagnosis of hematological malignancy\n* planned to receive an autologous or allogeneic HCT\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\n* Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n  * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n  * (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes):\n* history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma)\n* history of major stroke with obvious residual deficits\n* history of relapsing and remitting Multiple Sclerosis\n* active moderate to severe psychiatric symptoms due to primary psychiatric disorder\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form\n\nExclusion Criteria for Participants' Care-Partner:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\no Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n* other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria","19 Years",{"count":207,"type":21},114,[24],"Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.\n\nThe study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners.\n\nThe second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.",[211,212,27,213,214],"Leukemia","Lymphoma","Myelodysplastic Syndromes (MDS)","Myeloproliferative Neoplasm",[216],"Hematopoietic cell transplantation",{"date":34,"type":37},{"date":219,"type":37},"2021-11-18",{"date":221,"type":21},"2027-07",{"name":223,"class":44},"University of Nebraska",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":255},"100489347","phase-1-a-study-of-an-mmset-inhibitor-in-patients-with-relapsed-and-refractory-multiple-myeloma-100489347","NCT05651932","A Study of an MMSET Inhibitor in Patients With Relapsed and Refractory Multiple Myeloma","A Phase 1 Study of KTX-1001, an Oral, First-In-Class, Selective, and Potent MMSET Catalytic Inhibitor That Suppresses H3K36me2 in Patients With Relapsed and Refractory Multiple Myeloma","Key Inclusion Criteria for Dose-Expansion:\n\n* ≥ 18 years of age\n* ECOG score ≤ 1\n* Multiple myeloma (as per IMWG)\n\n  * Prior therapy for MM: Participants must have received at least 1 and up to 3 prior lines of therapy as defined by IMWG, and the following drug classes: PI, IMiD, and anti-CD38 antibody. For mezigdomide combination Cohorts B1 and B2, participants must have received at least 2 prior lines of therapy\n  * Participants must have a confirmed diagnosis of progressive MM (per IMWG), t(4;14) confirmed by fluorescence in situ hybridization (FISH) testing performed in a centralized Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory via fresh tumor biopsy.\n* Measurable disease, including at least 1 of the following criteria:\n\n  * Serum M protein ≥ 0.50 g\u002FdL (by SPEP)\n  * Serum IgA ≥ 0.50 g\u002FdL (IgA myeloma patients)\n  * Urine M protein ≥ 200 mg\u002F24 h (by UPEP)\n  * sFLC involved light chain ≥ 10 mg\u002FdL (100 mg\u002FL) (patients with abnormal sFLC ratio)\n  * Bone marrow plasma cells ≥ 30% (if only criterion for measurability)\n* Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)\n\nKey Exclusion Criteria for Dose-Expansion:\n\n* Treatment with the following therapies in the specified time period prior to first dose:\n\n  * Patients in Cohorts B1 and B2 must not have received prior mezigdomide treatment\n  * Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2\n  * Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D\n  * Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks\n  * Cellular therapies ≤ 8 weeks\n  * Autologous transplant \\\u003C 100 days\n  * Allogenic transplant ≤ 6 months, or \\> 6 months with active GVHD\n  * Major surgery ≤ 4 weeks\n* Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis\n* Active CNS disease: participants with previously treated stable CNS disease are eligible, except for Cohorts B1 and B2 for which known CNS myeloma involvement is completely excluded.\n* Inadequate bone marrow function\n* Inadequate renal, hepatic, pulmonary, and cardiac function\n* Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.\n* Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 7 days or 5 half-lives (whichever is longer) prior to first dose\n* Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)\n* Active malignancy not related to myeloma requiring therapy within \\\u003C 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.",{"count":232,"type":21},165,[57],"A Phase I study to evaluate the safety of a novel, orally available, selective, and potent small molecule inhibitor of the histone lysine methyl transferase MMSET (also known as NSD2\u002FWHSC1) to prevent the dimethylation of H3K36 in adult patients with relapsed or refractory multiple myeloma (RRMM).",[27,236,237],"Myeloma","Myeloma Multiple",[239,240,241,242,243,244,245,246],"NSD2","MMSET","WHSC1","T4;14","T(4;14)","translocation","myeloma","RRMM","2026-08-16",{"date":89,"type":37},{"date":250,"type":37},"2023-02-22",{"date":252,"type":21},"2028-06-30",{"name":254,"class":68},"K36 Therapeutics, Inc.",26,{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":274,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":155},"100317456","phase-2-administration-of-autologous-t-cells-genetically-engineered-to-express-t-cell-receptors-reactive-against-neoantigens-in-people-with-metastatic-cancer-100317456","NCT03412877","Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer","A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer","* INCLUSION CRITERIA:\n* Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection.\n\nNote: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas.\n\n* Documented diagnosis of cancer.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.\n  * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).\n* Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated.\n* Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant.\n* Participants with three (3) or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child.\n* Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology:\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology:\n\n  * ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry:\n\n  * Serum ALT\u002FAST less than or equal to 5.0 x ULN\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg\u002FdL.\n* Participants must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma.\n\n* For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1\u002FPD-L1, including but not limited to myocarditis and pneumonitis.\n\nNote: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met.\n\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.\n\nNote: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin.\n\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Participants who are receiving any other investigational agents.","72 Years",{"count":265,"type":21},285,[80],"Background:\n\nA person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person.\n\nObjective:\n\nTo see if gene transfer therapy of white blood cells can shrink tumors.\n\nEligibility:\n\nPeople with certain metastatic cancer for which standard treatments have not worked.\n\nDesign:\n\nParticipants may complete screening under another protocol. Screening includes:\n\n* Getting tumor cells from a previous procedure\n* Medical history\n* Physical exam\n* Scans\n* Blood, urine, heart, and lung tests\n\nThe study has 8 stages:\n\n1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm.\n2. Care at home over approximately 12 weeks.\n3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.\n4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs.\n5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart.\n6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.\n7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.\n8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.\n\n   ...",[269,270,271,138,272,273,27],"Endocrine Tumors","Non-Small Cell Lung Cancer","Ovarian Cancer","Gastrointestinal\u002FGenitourinary Cancers","Neuroendocrine Tumors",[275,276,277,278],"Gene Therapy","Immunotherapy","Cell Therapy","Adoptive Cell Therapy","2026-08-15",{"date":89,"type":37},{"date":282,"type":37},"2018-09-06",{"date":284,"type":21},"2029-03-23",{"name":286,"class":287},"National Cancer Institute (NCI)","NIH",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":297,"phases":4,"briefSummary":298,"conditions":299,"keywords":304,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":4,"leadSponsor":314,"locationsCount":315},"100184467","tissue-collection-for-studies-of-lymph-cancer-100184467","NCT01676805","Tissue Collection for Studies of Lymph Cancer","Lymphoid Malignancies and Precursors: Tissue Acquisition Protocol","* LYMPHOID MALIGNANCIES\u002FDISEASES: The following criteria apply only to patients with a known lymphoid malignancy or precursor\n\ndisease, as described:\n\nINCLUSION CRITERIA:\n\n* Patients with a known lymphoid malignancy or precursor disease to a lymphoid malignancy, including multiple myeloma, B-cell and T-cell lymphomas: including but not limited to diffuse large B-cell lymphoma (DLBCL), Hodgkin s lymphoma (HL), multiple myeloma (MM), lymphomatoid granulomatosis (LYG) and adult T-cell leukemia\u002Flymphoma (ATL).\n* Confirmation of pathological diagnosis is required from the Laboratory of Pathology, NCI. Tumor tissue that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care or required testing on an NIH research protocol will be used for diagnosis.\n* Age \\>= 18 years of age\n* Ability of patient or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document NOTE: Patients enrolling with a LAR must be co-enrolled on another study.\n\nEXCLUSION CRITERIA:\n\n* Pregnant individuals will not be eligible.\n* Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, and\u002For pulmonary dysfunction.\n* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.\n\nNON-LYMPHOID MALIGNANCIES\u002FDISEASES: The following criteria apply only to patients without a known lymphoid malignancy or precursor disease, as described:\n\nINCLUSION CRITERIA:\n\n-Patients without a known lymphoid malignancy or lymphoid precursor diagnosis who have a planned surgical procedure during which blood or normal lymph node(s)\u002Ftissue (i.e., those not with pre-determined likelihood of abnormality\u002F malignancy) may be obtained for research studies as part of this protocol.\n\nPatient is appropriate to undergo the surgical procedure planned, and consented for the same, as needed. NOTE: This study will not evaluate eligibility of the patient for surgery.\n\n* Age \\>= 18 years of age\n* Must be able and willing to sign informed consent\n\nEXCLUSION CRITERIA:\n\n* Pregnant individuals will not be eligible.\n* Other active malignancy. NOTE: Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible. Patients with a malignancy that has been treated with curative intent and who are without evidence of disease for \\>=2 years will also be eligible at the discretion of the investigator.\n* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.",{"count":296,"type":21},1295,"OBSERVATIONAL","Background:\n\n\\- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia\u002Flymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue.\n\nObjectives:\n\n\\- To collect tissue samples to study different types of lymph cancer.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history.\n* Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study.\n* Treatment will not be provided as part of this study.",[300,301,27,302,303],"Hodgkin Disease","Lymphoma, Non-Hodgkin","Lymphomatoid Granulomatosis","Leukemia-Lymphoma, Adult T-Cell",[305,306,307,308,309,310],"Developing Novel Treatment Approaches","Developing Therapeutic Agents","Analysis of Genetic and Genomic Biology","New Prognostic and Diagnostic Models","Analysis of Cellular and Molecular Biology","Natural History",{"date":89,"type":37},{"date":313,"type":37},"2012-09-21",{"name":286,"class":287},2,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":297,"phases":4,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":4,"leadSponsor":340,"locationsCount":341},"100125401","collection-of-tissue-samples-for-cancer-research-100125401","NCT00900198","Collection of Tissue Samples for Cancer Research","Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)","* INCLUSION CRITERIA - ADULT:\n* Patients 18 years of age and older who are being evaluated and\u002For treated for cancer at the NIH Clinical Center or at participating sites:\n\n  * Who have a newly diagnosed malignancy for which they have not yet received treatment, or\n  * Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:\n\n    * radiographic evidence of tumor growth and\u002For new metastases, or\n    * CBC w\u002Fdifferential and\u002For flow cytometry, or\n    * documented evidence by the treating physician of signs\u002Fsymptoms of clinical disease progression, or\n  * Who are currently undergoing treatment and for whom disease response has not yet been assessed,\n\n    ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.\n  * Patients with ongoing partial response (PR) or stable disease (SD) are eligible.\n\n    * For solid tumor diagnoses, confirmation of viable malignancy and\u002For \\\u003C90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.\n    * For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final flow cytometry report.\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.\n\nAt the NIH Clinical Center ONLY:\n\n* At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and\u002For treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.\n* Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and\u002For treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and\u002For MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.\n\n  * Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.\n\nEXCLUSION CRITERIA:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with cancer-like syndromes and\u002For blood disorders such as but not limited to systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia\u002Fhypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS).\n* Patients with invasive fungal infections.\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.\n  * Patients receiving antibiotics, antifungals, or antivirals for prophylaxis are permissible.\n  * Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible.\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR).\n\nINCLUSION CRITERIA - PEDIATRIC:\n\n* Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.\n* Ability and willingness to assent to participation, utilizing an explanation that is understandable\u002Fage appropriate, as well as receiving parental permission.\n\nAt the NIH Clinical Center ONLY\n\n-At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.\n\nEXCLUSION CRITERIA - PEDIATRIC:\n\nNote: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and\u002For other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.\n\n* Patients with invasive fungal infections\n* Patients with active and\u002For uncontrolled infections or who are still recovering from an infection:\n\n  * Actively febrile patients with uncertain etiology of febrile episode\n  * All antibiotics should be completed at least 1 week (7 days) prior to collection\n  * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\n  * Note: Use of antibiotics for prophylaxis is not an exclusion.\n* Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and\u002For positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.\n* Patients with Hepatitis A as indicated by anti-HAV IgM reactivity\n\n  --Note: Patients that are anti-HAV IgG reactive only are not excluded\n* Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.\n* Blood only collections from patients with partial or stable disease response:\n\n  * Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.\n  * Blood will not be collected from patients between doses within a single treatment cycle.","2 Months",{"count":325,"type":21},5000,"Background:\n\n-Patients who are being evaluated and\u002For treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.\n\nObjectives:\n\n* To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.\n* To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.\n\nEligibility:\n\n-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and\u002For treated for cancer at the NIH Clinical Center participating sites.\n\nDesign:\n\n* This is a multicenter tissue procurement protocol with NCI as the coordinating center.\n* For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.\n* For pediatric patients: tumor biopsy\u002Fresection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.\n* Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents\u002Fguardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.\n* This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.\n* Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.",[328,329,27,330],"Neoplasms","Lymphomas","Myelodysplastic Syndrome",[332,333,334,335,336,310],"Tissue Collection","Biospecimen","Assay Development","Tissue Acquisition","Tissue Biopsies",{"date":89,"type":37},{"date":339,"type":37},"2006-07-06",{"name":286,"class":287},17,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":357,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":155},"100619226","phase-1-systemic-anti-cancer-therapy-dose-modifications-for-individuals-with-duffy-null-phenotype-100619226","NCT07341867","Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype","A Pilot Study of Duffy Null-Specific Dose Modifications for Individuals With Duffy Null Phenotype Receiving Standard of Care Systemic Anti-Cancer Therapies","Inclusion Criteria:\n\n* Diagnosis of:\n\n  * Cohort 1: MM, based on IMWG criteria12, and currently requires treatment\n  * Cohort 2: Stage II or III TNBC, with definition per protocol Section 3.2.1 AND\n* Plan for treatment, per their treating physician, or currently receiving their first cycle (see 3.3.3 for definition) of:\n\n  * Cohort 1: Dara-RVd for MM\n  * Cohort 2: A Keynote 522-based regimen of carboplatin, paclitaxel, and pembrolizumab given as the first phase of neoadjuvant treatment for TNBC.\\*\\*\\*\n\n    * Participants are eligible even if the duration of carboplatin and paclitaxel goes beyond 4 cycles, or if the use of pembrolizumab, doxorubicin, and cyclophosphamide is not planned or is not certain, as long as neoadjuvant treatment starts with carboplatin-paclitaxel-pembrolizumab. This cohort will be referred to as \"Keynote 522\" for the remainder of the protocol.\n\nAND\n\n* Confirmed Duffy null phenotype\n\n  * Previous testing is acceptable if performed by a CLIA-approved test\n\nAND\n\n* Age \\>=18 years old\n\nExclusion Criteria:\n\n* Inability to understand and the willingness to sign a written informed consent document\n* ANC\\\u003C500 within 7 days of planned start of Cycle 1 Day 1.\n* Participants who have started treatment at the time of enrollment cannot have started Cycle 2 of therapy\n* Participants in Cohort 2 (TNBC) cannot have received any of the pembrolizumab, doxorubicin, and cyclophosphamide portion of therapy\n* Participants receiving any other investigational agents for any indication\n* Another known condition or medicine with known impacts on neutrophil counts or neutrophil function",{"count":350,"type":21},90,[57],"This study is comprised of a main study, an observational study, and optional survey studies. The main study is being done to see whether using Duffy null specific treatment dosing guidelines can reduce or delay dose modifications and avoid neutropenic fever (fever in the setting of low neutrophils) for people with Duffy null phenotype receiving treatment for multiple myeloma or triple negative breast cancer. The observational study is to collect dose modification and neutropenic fever information on patients who do not have the Duffy null phenotype and receive the same standard of care regimens to see if there are differences in dose modifications and neutropenic fever between the two groups. The survey studies seek to understand general health experiences and preferences and experiences specific to people with Duffy null phenotype.\n\nStudy Drugs Include:\n\n* Daratumumab\n* lenalidomide\n* bortezomib\n* dexamethasone\n* carboplatin\n* paclitaxel\n* pembrolizumab\n* cyclophosphamide\n* doxorubicin",[27,354,355,356],"Triple Negative Breast Cancer","Duffy Blood Group, Chemokine Receptor Gene Mutation","Duffy Blood Group, Chemokine Receptor Gene C.-67T>C",[358,27,354,359],"Duffy Null Phenotype","Dosing guidelines","2026-08-14",{"date":147,"type":37},{"date":363,"type":37},"2026-07-30",{"date":365,"type":21},"2029-03-31",{"name":367,"class":44},"Andrew Hantel, MD",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":297,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":155},"100261446","biospecimen-procurement-for-center-for-immuno-oncology-immunotherapy-protocols-100261446","NCT02682667","Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols","* INCLUSION CRITERIA:\n\n  1. Diagnosis of cancer, a premalignant\u002Fneoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant\u002Fneoplastic condition\n  2. Age \\>=18 years of age\n  3. ECOG performance status of 0-3.\n\n  5\\. Ability and willingness of subject to provide informed consent\n\nAdditional inclusion criteria pertinent only for participants undergoing apheresis\n\n1. Hemoglobin \\>= 8 mg\u002FdL and platelet count \\> 75 K\u002FmicroL\n2. Weight \\>= 48 kg\n3. Central line in place or adequate venous access\n\nEXCLUSION CRITERIA:\n\n1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.\n2. Inability to provide informed consent\n3. Pregnant or breastfeeding women","120 Years",{"count":376,"type":21},500,"Background:\n\nCancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.\n\nObjective:\n\nTo better understand the biology of malignancies and why certain cancers respond differently to treatment.\n\nEligibility:\n\nAdults at least 18 years old with cancer or a pre-cancerous condition.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.\n\nParticipants will send tissue blocks or slides from their original tumor biopsy.\n\nAt least once, participants will have a medical history, physical exam, and blood and urine tests.\n\nParticipants may have the following tests. They may have them more than once:\n\nApheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.\n\nBone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.\n\nPiece of cancer tissue taken by a needle and syringe.\n\nComputed tomography (CT) scan, magnetic resonance imaging (MRI) and\u002For positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.\n\nA small piece of skin removed.\n\nParticipants will be contacted by phone once a year to find out how they are doing.\n\n...",[27,301,303,300,270],[380,381,382,383,384,310],"Apheresis Products","Immunological","Diverse Malignan","Premalignant","Protein",{"date":147,"type":37},{"date":387,"type":37},"2016-04-11",{"date":389,"type":21},"2032-12-01",{"name":286,"class":287},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100635688","phase-3-cevostamab-in-combination-with-pomalidomide-and-dexamethasone-versus-standard-of-care-in-participants-with-previously-treated-multiple-myeloma-100635688","NCT07555938","Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma","A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy","CEVOLUTION","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.\n* Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible\n* MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria\n* Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide\n* Participants must have measurable disease during screening\n\nExclusion Criteria:\n\n* Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)\n* Plasma cell leukemia or circulating plasma cell count exceeding 500 cells\u002Fliter (L) or 5% of the peripheral blood white cells\n* GI disease that might significantly alter absorption of oral drugs\n* Participants must not have any ongoing CNS disease or non-secretory myeloma",{"count":400,"type":21},380,[402],"PHASE3","The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.",[27],"2026-08-13",{"date":360,"type":37},{"date":408,"type":37},"2026-06-23",{"date":410,"type":21},"2033-01-31",{"name":412,"class":68},"Hoffmann-La Roche",40,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":17,"minAge":422,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":446,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100626796","phase-2-determine-trial-treatment-arm-07-dabrafenib-in-combination-with-trametinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-braf-v600-mutation-positive-cancers-100626796","NCT07440290","DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\\* \\*When dabrafenib- and trametinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.\n\nInclusion criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.\n\nB. Patients ≥1 year old and ≥8 kg in body weight.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n• Have a negative serum or urine pregnancy test before enrolment and;\n\n• Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \\\u003C1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nPatients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks after the last administration of dabrafenib and 16 weeks after the last administration of trametinib (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (male condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male partners with partners who are women of childbearing potential should also be advised of the benefit for their partner of using a highly effective method of contraception, such as:\n\n  i. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \\[oral, intravaginal or transdermal\\]), ii. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), iii. IUD, iv. intrauterine hormone-releasing system (IUS), v. bilateral tubal occlusion, vi. total sexual abstinence.\n* Male patients with pregnant or breastfeeding partners must be advised to use barrier method contraception (male condom) to prevent drug exposure of the foetus or neonate, even if vasectomised.\n* Male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility\n\nExclusion criteria:\n\nA. Diagnosis of one of the following BRAF V600E mutation-positive cancers:\n\n* Colorectal cancer in adult (≥18 years) patients;\n* Unresectable or metastatic melanoma in adult (≥18 years) patients;\n* Advanced non-small cell lung cancer in adult (≥18 years) patients;\n* Gliomas harbouring a BRAF V600E mutation in paediatric (1 to \\\u003C16 years) or TYA (16 to \\\u003C18 years) patients.\n\nB. Previous treatment with dabrafenib and trametinib in combination (or other BRAF and MEK inhibitors in combination) for the current indication.\n\nC. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or for two weeks following their last dose of dabrafenib or 16 weeks following their last dose of trametinib, whichever is later.\n\nD. Known hypersensitivity to dabrafenib or trametinib or any of the excipients. See the current relevant SmPCs (UK) for the full lists.\n\nE. Patients with a history of retinal vein occlusion.\n\nF. Any impairment of gastrointestinal (GI) function of uncontrolled GI disease that may significantly alter the administration or absorption of dabrafenib and\u002For trametinib (e.g. history of diverticulitis, metastases to the GI tract, uncontrolled Crohn's disease, uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome or short gut syndrome).\n\nG. Clinically significant cardiac or cerebrovascular disease as defined by:\n\n* Unstable angina within three months prior to screening;\n* Myocardial infarction within three months prior to screening;\n* History of documented congestive heart failure (New York Heart Association functional classification III\u002FIV) etc.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) within three months prior to screening.\n\n• Patients with primary central nervous system (CNS) tumours may be considered unless intratumoural bleeding has occurred within two weeks prior to the first dose of dabrafenib and trametinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nH. Patients who were administered a live, attenuated vaccine within 28 days prior to initiation of treatment, or anticipation of need for such a vaccine during investigational medicinal product (IMP) treatment or within six months after the final dose of dabrafenib and trametinib.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of dabrafenib and trametinib including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided that each of the following conditions are met:\n\n* CD4 count ≥350\u002FµL;\n* Undetectable viral load;\n* Receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* No HIV\u002Facquired immune deficiency syndrome associated opportunistic infection in the last 12 months.\n\nJ. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial (including absorption of oral medications) that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.","1 Year",{"count":424,"type":21},30,[80,402],"This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600.\n\nInvestigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[428,429,430,431,432,433,434,435,135,436,437,438,439,440,441,442,27,443,444,445],"Haematological Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Neoplasms by Site","Gastrointestinal Cancer","Non-Melanoma Skin Cancer (NMSC)","Langerhans Cell Histiocytosis (LCH)","Erdheim-Chester Disease","Thyroid Carcinoma, Papillary","Ovarian Neoplasms","Colorectal Neoplasms","Laryngeal Neoplasms","Carcinoma, Non-Small Cell-Lung","Glioma","Thyroid Carcinoma, Anaplastic","Solid Tumour","Pancreatic Diseases",[447,448,135,449,450,451,452,453,454,455,432,456,457,458,459,460,461,462,463],"Adult","Antineoplastic Agents","Child","Dabrafenib","Malignancy","Malignant Neoplasms","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Paediatric","Precision Medicine","Proto-Oncogene Proteins B-raf","Protein Kinase Inhibitors","Rare","Trametinib","Tumour-Agnostic","Young adult",{"date":147,"type":37},{"date":466,"type":37},"2026-04-01",{"date":468,"type":21},"2029-10",{"name":470,"class":44},"Cancer Research UK",27,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100624408","phase-1-a-study-to-evaluate-adverse-events-change-in-disease-activity-tolerability-and-how-intravenous-abbv-438-moves-through-the-body-in-adult-participants-with-multiple-myeloma-mm-100624408","NCT07409246","A Study to Evaluate Adverse Events, Change in Disease Activity, Tolerability, and How Intravenous ABBV-438 Moves Through the Body in Adult Participants With Multiple Myeloma (MM)","A Phase 1, First-in-Human, Open Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ABBV-438 in Adult Subjects With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Has relapsed or refractory Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the standard International Myeloma Working Group (IMWG) (2016) response criteria:\n\n  * Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy;\n  * Refractory defined as disease that is nonresponsive (failure to achieve minimal response) while on last therapy, or progresses within 60 days of last therapy.\n* Has measurable disease at screening, defined by at least 1 of the following within 28 days prior to enrollment:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>=5 g\u002FL); OR;\n  * Urine M-protein \\>= 200 mg\u002F24 hours; OR;\n  * Involved serum free light chain (sFLC) \\>= 10 mg\u002FdL (100mg\u002FL), provided serum FLC ratio is abnormal;\n  * Must have had 3 or more prior lines of therapy with exposure to a proteasome inhibitor (PI), an immunomodulatory imide drugs (IMiD), and an anti-CD38 therapy and are intolerant to, or unable to access, available therapies that are known to confer clinical benefit to participants with relapsed or refractory (R\u002FR) MM. Note: A line of therapy consists of relapsed or refractory 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.\n\nExclusion Criteria:\n\n* Known history of Central Nervous System involvement by MM.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.",{"count":480,"type":21},127,[57],"Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety, tolerability, and how ABBV-438 moves through the body, in adult participants with relapsed\u002Frefractory (R\u002FR) MM. Adverse events, tolerability, how ABBV-438 moves through the body will be assessed.\n\nABBV-438 is an investigational drug being developed for the treatment of R\u002FR MM. Study doctors put the participants in groups called treatment arms broken into 2 parts. ABBV-438 will be given alone and multiple doses will be explored. This study will include a dose escalation phase (Part 1) to determine the best dose of ABBV-438, followed by a dose expansion phase (Part 2) to confirm the dose. Approximately 127 adult participants with R\u002FR MM will be enrolled in the study in approximately 24 sites worldwide.\n\nParticipants will receive intravenous (IV) ABBV-438 alone first in multiple doses in the dose escalation phase (Part 1); then in 1 of 2 doses from Part 1 in the dose expansion phase (Part 2). The overall study duration will be approximately 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[27],[27,485,135],"ABBV-438",{"date":360,"type":37},{"date":488,"type":37},"2026-02-27",{"date":490,"type":21},"2031-11",{"name":492,"class":68},"AbbVie",11,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":155},"100614872","phase-3-belantamab-mafodotin-or-daratumumab-with-bortezomib-lenalidomide-and-dexamethasone-for-newly-diagnosed-multiple-myeloma-100614872","NCT07285239","Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","Randomized Phase 3 Trial of Belantamab Mafodotin or Daratumumab in Combination With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","PrE1005","Eligibility Criteria:\n\n* Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of any myeloma treatment.\n* Patient must be considered ineligible for autologous stem cell transplantation by the treating physician because of their age (≥ 70 years) or aged 18 - 70 years with the presence of underlying medical conditions likely to have a negative impact on tolerability of high-dose chemotherapy with stem-cell transplantation, making them transplant ineligible, OR transplant-eligible and refusing stem-cell transplantation until first relapse or later.\n* Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization.\n\n  * ≥ 1g\u002FdL monoclonal protein (M-protein) on serum protein electrophoresis\n  * Involved free light chain ≥ 10 mg\u002FdL or ≥ 100 mg\u002FL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\\u003C0.26 or \\>1.65)\n  * ≥ 200 mg\u002F24 hours of monoclonal protein on a 24-hour urine protein electrophoresis\n  * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)\n* Patient must be ≥ 18 years and \\\u003C80 years of age.\n* Patient must have an Eastern Cooperative Group (ECOG) Performance Status (PS) of 0-2 (PS 3 allowed if secondary to pain).\n* Patient must have IMWG Frailty Score \\\u003C2.\n* Patient must have the ability to understand and willingness to sign a written informed consent document.\n* Patient must be willing to provide bone marrow (aspirate and\u002For biopsy) and blood samples for determination of International Myeloma Society (IMS) risk status and for research. Indeterminate patients with missing or unevaluable samples will be excluded.\n* Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there is no residual toxicity related to radiation and blood counts meet the study requirements. NOTE: Patients who have received prior treatment for smoldering multiple myeloma (SMM) are eligible.\n* Patient must have a Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), and serum Free Light Chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and\u002For aspirate is required within 28 days prior to registration if measurable disease is only present in bone marrow. Otherwise, a bone marrow examination must have been performed within 90 days prior to registration.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 2 weeks prior to registration.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fmicroliter (mcL)\n  * Platelets ˃75,000\u002FmcL\n  * Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin\n  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with documented Gilbert's disease\n* Patient must agree to register to the mandatory lenalidomide (Revlimid) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the REMS program.\n* Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 3 months after the last dose of protocol treatment.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patient must be class 2 or better.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients must not have peripheral neuropathy ≥ Grade 2 on clinical examination or Grade 1 with pain at time of registration.\n* Patients must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n* Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.\n* Patients must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.\n* Patients must not have current corneal epithelial disease except mild punctuate keratopathy.\n* Contact lenses must be avoided for participants while they are receiving belantamab mafodotin treatment unless cleared by an eye-care specialist. If cleared for use, bandaged contact lenses are specifically recommended. Contact lens use may be restarted after discontinuation of belantamab mafodotin treatment, provided the eye-care specialist confirms there are no other contraindications.\n* Patients must not have symptomatic amyloidosis or active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma-proliferative disorder, skin changes) at the time of screening.\n* Patients must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol.","79 Years",{"count":376,"type":21},[402],"Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.\n\nBelantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.\n\nMinimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.\n\nThe purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and\u002For prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.",[27],[508,509,510,113,511,512,513,514,515,516],"Newly Diagnosed High-Risk Multiple Myeloma","Transplant Ineligible Multiple Myeloma","High-Risk Cytogenetic Multiple Myeloma","Daratumumab-Hyaluronidase","Daratumumab","Bortezomib","Lenalidomide","Decadron","Dexamethasone",{"date":147,"type":37},{"date":519,"type":21},"2026-09",{"date":521,"type":21},"2034-06",{"name":523,"class":44},"PrECOG, LLC.",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":536,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100601020","phase-1-a-study-of-teclistamab-and-mezigdomide-in-people-with-multiple-myeloma-100601020","NCT07105059","A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma","Teclistamab and Mezigdomide for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.\n2. Patients need to have measurable disease defined by one or more of the following:\n\n   1. Serum myeloma (M)-protein greater than or equal to 0.5 g\u002FdL (5 g\u002FL).\n   2. Urine M-protein greater or equal to 200 mg\u002F24 h.\n   3. Involved light chain (either kappa or lambda) \\>10 mg\u002FdL with an abnormal kappa: lambda ratio\n   4. Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.\n\n      Increase is defined as a 50% and at least 1 cm increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion.\n   5. A bone marrow biopsy demonstrating \\>30% infiltration of clonal plasma cells.\n3. Patients who have received prior BCMA-directed therapy \\> 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell \\[CAR T\\] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.\n4. Patients who have received bispecific antibodies \\>60 days prior with targets other than BCMA are eligible.\n5. Patients who have received allogeneic stem cell transplantation \\>6 months prior are eligible.\n6. Age ≥18 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. PS-2 is permitted if PS is due solely to bone pain.\n8. Fulfil the criteria for Adequate Organ System Function Based on Safety Assessments:\n\n   Hematologic:\n   * Hemoglobin ≥8 g\u002FdL (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)\n   * Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF) before the screening and laboratory test\n   * Platelets ≥75 × 10\\^9\u002FL in participants in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥50×109 \u002FL in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the screening laboratory test)\n\n   Chemistry:\n   * Total bilirubin ≤2 × ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome (in which case if total bilirubin is \\>2×ULN, then direct bilirubin ≤1.5×ULN is required)\n   * AST and ALT ≤2.5 × ULN\n   * eGFR ≥30 mL\u002Fmin Calculated by CKD-EPI formula adjusted for body surface area (BSA): (mL\u002Fmin\u002F1.73 m2) x BSA\u002F1.73)\n   * Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6. mg\u002FdL (≤1.6 mmol\u002FL)\n9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1, with the exception of peripheral neuropathy attributable to bortezomib.\n10. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    ° Is not a woman of childbearing potential (WOCBP)\n\n    Nonchildbearing potential is defined as follows (by other than medical reasons):\n    * ≥45 years of age and has not had menses for \\>1 year\n    * Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n    * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure OR\n    * Is a WOCBP and agrees to use two different contraceptive methods that are highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency , during the intervention period and for at least 6 months after the last dose of study intervention.\n    * WOCBP must have two negative serum or urine pregnancy tests with 10-14 days in between prior to treatment with mezigdomide. The latter must be within 15 days of starting mezigdomide. WOCBP must agree to use two highly effective methods of contraception (i.e. copper-containing intrauterine device, established use of oral, inserted, injected or implanted hormonal method of contraception, or male\u002Ffemale sterilization, etc.\n    * WOCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n\n    The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Pregnancy prevention while on mezigdomide treatment is All WOCBP must agree and adhere to all testing and contraception requirements in the mezigdomide Global Pregnancy Prevention Plan (PPP). Duration of contraception for WOCBP must be in accordance with the mezigdomide Global PPP\n11. Male participants: Male participants are eligible to participate if they agree to the following: male participants must agree to practice complete abstinence or agree to use a condom during sexual contact with a pregnant partner or an WOCBP while taking mezigdomide, during dose interruptions, and for 28 days after the last dose of mezigdomide, even if they have undergone a successful vasectomy (ie, with documented azoospermia 90 days after the procedure). See mezigdomide Global PPP, Appendix 3. Male participants must agree not to donate sperm for the purpose of reproduction during this period.\n12. Signed and dated Informed Consent by study participant.\n13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with a BCMA targeted bispecific antibody\n2. Prior treatment with mezigdomide\n3. Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.\n4. Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.\n5. Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited \\[i.e., ≤ 25% of bone marrow in field\\] radiation therapy during this period).\n6. Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed\n7. Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.\n8. Patients who received CAR T therapy within 90 days prior to study enrollment\n9. Patients with primary AL amyloidosis will be excluded.\n10. Participant must not have had major surgery ≤4 weeks prior to initiating study treatment.\n11. Evidence of active internal bleeding.\n12. Presence of active renal condition. Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfill criteria given\n13. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).\n14. Subject has active or prior history of malignancy, other than multiple myeloma, unless the subject has been free of the disease or medically stable for ≥ 2 years. The only allowed exceptions are the below listed malignancies treated within the last 24 months and that are considered cured:\n\n    * Non-muscle invasive bladder cancer\n    * Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment) The participant must not be receiving active therapy, other than hormonal therapy for this disease. Presence of low risk prostate cancer per NCCN on active surveillance is permitted.\n15. Evidence of cardiovascular risk including any of the following:\n\n    * Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n    * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening\n    * Stroke, transient ischemic attack, or seizure within 6 months prior to randomization\n    * Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n16. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or mezigdomide, or any of the components of the study treatment.\n17. Pregnant or lactating individual.\n18. Active infection requiring treatment.\n19. Participant has known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n\n    1. Established antiretroviral therapy (ART) for at least 6 months and HIV viral load \\\u003C400 copies\u002FmL, and\n    2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL, and\n    3. No history of acquired immunodeficiency s-defining opportunistic infections or other acquired immune deficiency syndrome (AIDS)-defining conditions within the last 12 months and\n    4. Not receiving highly active anti-retroviral therapy, and\n    5. Not receiving antiretroviral therapy that may interfere with study treatment\n20. Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb at Screening or within 3 months prior to first dose of study treatment). Note: Participants with positive Hepatitis B antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis B DNA test is obtained.\n21. Active Hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Subjects with a history of HCV antibody positivity must undergo HCV RNA testing. The result needs to be negative for trial eligibility.\n22. Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n23. Administration of strong CYP3A modulators or proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study treatment.",{"count":532,"type":21},18,[57],"The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed\u002Frefractory multiple myeloma (MM).",[27],[537,538,539,540,541],"Teclistamab","Mezigdomide","Relapsed or refractory multiple myeloma","24-393","MATRIX (Mezigdomide And Teclistamab to Relieve Immune eXhaustion)",{"date":147,"type":37},{"date":544,"type":37},"2025-08-08",{"date":546,"type":21},"2028-08-08",{"name":548,"class":44},"Memorial Sloan Kettering Cancer Center",7,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":559,"briefSummary":560,"conditions":561,"keywords":562,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":584},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":558,"type":21},492,[402],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[27],[563,564,565,566,567,236,568,569,570,571,572,573,574,513,575,576],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Carfilzomib","PF-06863135",{"date":360,"type":37},{"date":579,"type":37},"2024-02-08",{"date":581,"type":21},"2027-12-30",{"name":583,"class":68},"Pfizer",270,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":592,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":599,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":155},"100538863","discovery-evaluating-a-decision-support-tool-for-adults-seen-in-hematologyoncology-clinics-100538863","NCT06296368","DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology\u002FOncology Clinics","DISCOVERY","Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n1. Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.\n2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n3. Age ≥ 60 years at the time of consent.\n4. New patient to either the hematologic malignancies clinic or the bone marrow transplant\u002Fcellular therapy clinic.\n\nExclusion Criteria\n\nAll subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:\n\n1\\. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention.","60 Years",{"count":376,"type":21},[24],"The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.",[597,212,27,211,598],"Hematologic Malignancies","Blood Cancers",[600,601,602],"decision support tool","pragmatic study","best-worst scaling","2026-08-12",{"date":360,"type":37},{"date":606,"type":37},"2024-06-21",{"date":152,"type":21},{"name":609,"class":44},"UNC Lineberger Comprehensive Cancer Center",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":619,"briefSummary":620,"conditions":621,"keywords":624,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":155},"100524063","phase-2-18f-fluciclovine-petct-in-multiple-myeloma-100524063","NCT06103838","18F-Fluciclovine PET\u002FCT in Multiple Myeloma","A Phase II Trial Evaluating 18F-Fluciclovine PET\u002FCT in Multiple Myeloma","* INCLUSION CRITERIA:\n* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g\u002FdL and\u002For bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\\u003C=10 g\u002FdL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg\u002FdL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg\u002FdL, or\n  * Lytic bone lesions on X-ray, CT, or PET\u002FCT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved\u002Fun-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g\u002Fdl\n  * Urine monoclonal protein \\> 200 mg\u002F24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg\u002FdL AND abnormal kappa\u002Flambda ratio\n  * A measurable lesion on PET\u002FCT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and\u002For refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\\u003C= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.",{"count":618,"type":21},60,[80],"Background:\n\nMultiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.\n\nObjective:\n\nTo find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.\n\nEligibility:\n\nAdults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).\n\nDesign:\n\nParticipants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET\u002FCT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET\u002FCT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.\n\nAll participants will have a third study visit after 5 years or when their disease progresses.",[27,622,623],"Newly Diagnosed Multiple Myeloma (NDMM)","Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[246,625,626,627,628,629,27],"NDMM","18F-FDG PET\u002FCT","PET\u002FCT","18F-fluciclovine","Imaging",{"date":405,"type":37},{"date":632,"type":37},"2024-03-25",{"date":634,"type":21},"2032-12-06",{"name":286,"class":287},{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":649,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":657},"100440817","phase-3-a-study-to-learn-about-the-study-medicine-elranatamab-alone-and-with-daratumumab-in-people-with-multiple-myeloma-who-have-received-other-treatments-100440817","NCT05020236","A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments","AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR","MAGNETISMM-5","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).\n* Measurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n  * Serum M-protein ≥0.5 g\u002FdL.\n  * Urinary M-protein excretion ≥200 mg\u002F24 hours.\n  * Serum immunoglobulin FLC ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Prior anti-multiple myeloma therapy including treatment with lenalidomide.\n* ECOG performance status ≤2.\n* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.\n* Not pregnant and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* POEMS Syndrome.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n* Previous treatment with a BCMA-directed therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.",{"count":645,"type":21},893,[402],"The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study.\n\nPart 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab.\n\nPeople participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab.\n\nPart 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab.\n\nAll people participating in the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.",[27],[563,576,564,565,566,567,512,573,568,569,570,650],"MagnetisMM-5",{"date":360,"type":37},{"date":653,"type":37},"2021-10-04",{"date":655,"type":21},"2027-05-31",{"name":583,"class":68},237,{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":664,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":549},"100473396","compassionate-communication-and-advance-care-planning-to-improve-end-of-life-care-in-treatment-of-hematological-disease-act-100473396","NCT05444348","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study","ACT","Inclusion Criteria:\n\nPatients must:\n\n* Be at least 18 years of age\n* Have a diagnosis of one of the following:\n* High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS\u002FMPN),\n* Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse\n* Lymphoma: Age≥80 or relapse or refractory or palliative treatment\n* Multiple myeloma(MM): Age≥80 or relapsed or refractory\n\nHave limited treatment options. Provide informed consent. Have sufficient Danish skills to complete intervention sessions and data collection\n\nAn informal caregiver is identified by the patient as the primary provider of informal physical, practical or emotional support and must:\n\n* Be at least 18 years of age\n* Be able to accompany patients to intervention appointments\n* Provide informed consent\n* Have sufficient Danish skills to complete intervention sessions and data collection\n\nPhysicians:\n\n* specialized in hematology\n* treating patients with High risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nNurses:\n\n* treating patients with High-risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nExclusion Criteria:\n\nPatient and caregiver are excluded if one of them is:\n\n\\- Suffering from a severe psychiatric disorder\n\nPhysicians and nurses:\n\n\\- If they do not meet the inclusion criterion.",{"count":667,"type":21},920,[24],"Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept \"Advance Consultations Concerning participants Life and Treatment\" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.",[27,671,212,672],"Myelodysplastic Syndromes","Acute Myeloid Leukemia","2026-08-11",{"date":603,"type":37},{"date":676,"type":37},"2022-08-01",{"date":678,"type":21},"2028-07-01",{"name":680,"class":44},"Christoffer Johansen",{"id":682,"slug":683,"hasResults":12,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":4,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":22,"phases":690,"briefSummary":691,"conditions":692,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":693,"lastUpdatePostDateStruct":694,"startDateStruct":695,"completionDateStruct":696,"leadSponsor":698,"locationsCount":155},"100651812","phase-2-a-open-label-phase-in-participants-with-multiple-myeloma-100651812","NCT07764861","A Open-Label Phase in Participants With Multiple Myeloma","A Multi-Center, Open-Label Phase II Study of IBI3003 in Combination With Anti-CD38 Monoclonal Antibody in Participants With Multiple Myeloma","Inclusion Criteria:\n\n* 1\\. Aged at least 18 years old;\n* 2\\. Initial diagnosis of multiple myeloma documented according to International Myeloma Working Group (IMWG) diagnostic criteria.Multiple myeloma is defined as clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma, and any one or more of the following myeloma-defining events: • Evidence of end-organ damage attributable to the underlying plasma cell proliferative disorder, including the following: Hypercalcemia: serum calcium \\> 0.25 mmol\u002FL (\\> 1 mg\u002FdL) above the upper limit of normal or corrected serum calcium \\> 2.75 mmol\u002FL (\\> 11 mg\u002FdL); renal insufficiency: creatinine clearance \\\u003C 40 mL\u002Fmin or serum creatinine \\> 177 μmol\u002FL (\\> 2 mg\u002FdL); anemia: hemoglobin value \\> 2 g\u002FdL below the lower limit of normal or hemoglobin value \\\u003C 10 g\u002FdL; bone lesions: one or more osteolytic lesions on skeletal radiographs, computed tomography (CT), or positron emission tomography (PET)-CT.\n\n  • Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥ 60%; involved-to-uninvolved serum free light chain ratio ≥ 100 \\[involved serum free light chain (FLC) level must be ≥ 100 mg\u002FL\\]; \\> 1 focal lesion (at least 5 mm in size) on magnetic resonance imaging (MRI) examination.\n* 3.Safety run-in stage: Relapsed or refractory measurable multiple myeloma who have previously received ≥ 1 line of anti-myeloma therapy (including treatment with at least one proteasome inhibitor and one immunomodulatory drug), and the participant must be relapsed or refractory to the most recent treatment.Participants previously exposed to anti-CD38 monoclonal antibodies may also be enrolled (a 90-day washout period is required).\n\nNote: Refractory to antimyeloma therapy requires failure to achieve minimal response (receipt of at least 2 complete cycles) or progression during treatment (no requirement for number of treatment cycles), or progression within 60 days of last treatment.\n\nCohort 1: Participants with newly diagnosed multiple myeloma who are ineligible for or refusing ASCT.\n\nCohort 2: Participants with newly diagnosed multiple myeloma who are eligible for and interested in ASCT.\n\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 5\\. At least one of the following measurable disease indicators: • Serum M protein \\>= 5 g\u002FL (for IgA and IgD subtypes, quantitative immunoglobulin measurement can be used to replace M protein); • Urine M protein \\>= 200mg\u002F24h; • FLC test: involved FLC level \\>= 100 mg\u002FL and abnormal FLC ratio (\\\u003C 0.26 or \\> 1.65).\n\nExclusion Criteria:\n\n* 1\\. All subjects have previously received any treatment targeting BCMA and any treatment targeting GPRC5D.Participants who have received either a BCMA-directed or GPRC5D-directed therapy are allowed.\n* 2\\. Known active central nervous system (Central Nervous System, CNS) involvement or clinical symptoms of meningeal involvement of multiple myeloma.\n* 3\\. Has amyloidosis, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, solitary plasmacytoma, or smoldering (asymptomatic) multiple myeloma as defined by IMWG criteria.\n* 4\\. Patients with spinal cord compression resulting in limited self-care at present or within 6 months before signing the informed consent form, or expected to result in such restrictions during study participation.\n* 5\\. History of primary immunodeficiency.\n* 6\\. Other malignant tumors (except for cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial neoplasia, cervical carcinoma in situ, or other non-invasive or indolent malignant tumors) at the time of enrollment or within 3 years prior to enrollment.\n* 7\\. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to the first dose of study drug, or received autologous stem cell transplantation within 3 months prior to the first dose of study drug.\n* 8\\. History of organ transplantation.\n* 9\\. Active graft-versus-host disease.",{"count":689,"type":21},120,[80],"This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.",[27],"2026-08-10",{"date":360,"type":37},{"date":279,"type":21},{"date":697,"type":21},"2031-06-30",{"name":699,"class":68},"Innovent Biologics (Suzhou) Co. Ltd."]