[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-mm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-mm":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,45,75,99,132,162,191,214,240,262,286,316,340,366,390,418,442,461,490,514,538,565,590,607,627],{"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":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641950","gustabor-phase-2---treating-taste-changes-during-cancer-therapy-a-randomized-study-evaluating-an-ai--based-nutrition-intervention-100641950",false,"NCT07649681","Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention","GustaborRCT","Inclusion Criteria:\n\n* Age ≥ 18\n* Suffering from one of the following tumor entities: Multiple myeloma, melanoma, urogenital cancer 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},198,"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.\n\nThis randomized study aims to compare the effectiveness of individualized dietary recommendations (Gustabor group) with the current standard of care -general recommendations (Control group). Participants will undergo an objective assessment of taste disorders using taste strips and questionnaires. Based on the results, the Gustabor group will receive both general and specific dietary suggestions. These will be accomapnied by AI-generated recipe suggestions tailored to specific taste disorders (e.g., more cold foods in cases of metallic taste). The control group will receive the current standard: a flyer containing general dietary advice for oncology patients previously shown to be beneficial for managing taste alterations. The primary endpoint is the PG-SGA score within 12 weeks of inclusion.",[27,28,29,30,31],"Multiple Myeloma (MM)","GI Cancer","Taste Disorder","Melanoma (Skin Cancer)","Urogenital Cancers","RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":36},"2026-07-24",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"Wuerzburg University Hospital","OTHER",6,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100649498","phase-1-a-phase-1-study-of-ub-vv500-with-rapamycin-in-relapsedrefractory-multiple-myeloma-100649498","NCT07735546","A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed\u002FRefractory Multiple Myeloma","A Phase 1, Open-label, Multicenter Study of UB-VV500 With Rapamycin in Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. 18 years or older\n2. Provides voluntary written informed consent\n3. Relapsed or refractory multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody\n4. Measurable disease following completion of most recent anticancer therapy\n5. No serious concomitant diseases or active\u002Funcontrolled infections\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ function\n\nExclusion Criteria:\n\n1. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis\n2. Solitary plasmacytomas without evidence of systemic disease\n3. Women who are pregnant or breastfeeding\n4. Current isolated central nervous system (CNS) involvement\n5. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \\[TCR\\] fusion constructs, TCR T cells, and CAR T cells)\n6. History of or active human immunodeficiency virus (HIV)\n7. Active or chronic hepatitis B, or active hepatitis C\n8. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease\n9. Ongoing CNS disease that would preclude neurologic assessment\n10. Uncontrolled angina or other acute heart disease\n11. Currently receiving treatment in another interventional clinical trial.",{"count":53,"type":21},100,[55],"PHASE1","This study is a Phase 1 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV500. The study will enroll patients with relapsed\u002Frefractory multiple myeloma.",[58,27],"Multiple Myeloma in Relapse",[60,61,62,63],"CAR T","chimeric antigen receptor","BCMA","GPRC5D","NOT_YET_RECRUITING","2026-08-13",{"date":67,"type":36},"2026-08-17",{"date":69,"type":21},"2026-10-01",{"date":71,"type":21},"2029-12-31",{"name":73,"class":74},"Umoja Biopharma","INDUSTRY",{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100614470","phase-1-a-study-to-learn-about-the-effects-of-cemsidomide-in-combination-with-elranatamab-in-relapsedrefractory-multiple-myeloma-subjects-100614470","NCT07280013","A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed\u002FRefractory Multiple Myeloma Subjects","A Phase 1B, Open-label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of Cemsidomide in Combination With Elranatamab in Relapsed\u002FRefractory Multiple Myeloma Subjects","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma as defined by IMWG criteria\n* Measurable disease based on IMWG criteria\n* Received 2-4 prior lines of therapy (escalation part) and 1-3 prior lines of therapy (expansion part) for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1\u002F3 degrader)\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Active plasma cell leukemia, Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS\n* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease\n* Participants with any active, uncontrolled bacterial, fungal, or viral infection\n* Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy\n* Administration with an investigational product within 30 days preceding the first dose of study intervention\n* Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function",{"count":83,"type":21},60,[55],"The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.\n\nThe first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.\n\nCemsidomide will be taken orally each cycle for 14 days on\u002F14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.",[27],[88],"multiple myeloma, cemsidomide, CFT7455, elranatamab, PF-06863135, relapsed, refractory, RRMM, BCMA, bispecific antibody, BiTE, TCE, ELREXFIO","2026-08-11",{"date":91,"type":36},"2026-08-12",{"date":93,"type":36},"2026-02-06",{"date":95,"type":21},"2029-06",{"name":97,"class":74},"C4 Therapeutics, Inc.",20,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100642899","phase-2-a-study-of-elranatamab-outpatient-administration-in-patients-with-relapsedrefractory-multiple-myeloma-100642899","NCT07637578","A Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Phase II, Nonrandomized, Single-Arm Study of Elranatamab Outpatient Administration in Patients With Relapsed\u002FRefractory Multiple Myeloma (CORE-MM)","CORE-MM","Inclusion Criteria:\n\n1. Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses\n2. At least 18 years-of-age at the time of signature of the ICF\n3. Has documented diagnosis of MM according to IMWG diagnostic criteria\n4. Measurable disease at screening, as assessed by local laboratory, defined by any of the following:\n\n   1. Serum M-protein level ≥0.5 g\u002FdL\n   2. Urine M-protein level ≥200 mg\u002F24 hours\n   3. Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda FLC ratio\n   4. For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)\n5. Relapsed and\u002For refractory MM received ≥1 prior line of therapy and must have been exposed to both lenalidomide and an anti-CD38 monoclonal antibody (in the same or separate prior lines)\n6. ECOG Performance Status score of 0 or 1\n7. Human immunodeficiency virus (HIV)-positive participants are eligible if they meet all of the following:\n\n   1. No detectable viral load (i.e., \\\u003C50 copies\u002FmL) at screening\n   2. CD4+ count \\>300 cells\u002Fmm3 at screening\n   3. No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 6 months of screening\n   4. Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance\u002Fprogression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. HAART that could interfere with study treatment is excluded (consult the Medical Monitor for a review of medications prior to enrollment, if needed).\n8. Adequate organ function, defined as follows:\n\n   1. Hemoglobin (Hgb) ≥8 g\u002FdL (≥5 mmol\u002FL; without prior red blood cell \\[RBC\\] transfusion within 7 days before laboratory testing; recombinant human erythropoietin use is permitted)\n   2. Platelets \\>50 x109\u002FL\n   3. Absolute neutrophil count (ANC) ≥10.x109\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)\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5xupper limit of normal (ULN)\n   5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin based on Modified Diet in Renal Disease (MDRD) 4-variable formula calculation or creatinine clearance measured by 24-hour urine collection\n   6. Total bilirubin \\\u003C1.5xULN (isolated total bilirubin) ≥1.5xULN with conjugated \\[direct\\] bilirubin \\\u003C1.5xULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias)\n   7. Corrected serum calcium ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Participants must be able and willing to receive prophylaxis for Varicella zoster virus (VZV) and Pneumocystis jirovecii pneumonia (PJP) as follows:\n\n   1. VZV prophylaxis (e.g. acyclovir or valacyclovir) must be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n   2. PJP prophylaxis must likewise be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose\n10. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n11. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception. R\n12. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n13. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n14. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n\nExclusion Criteria:\n\n1. History of antitumor therapy as follows, before the first dose of study drug\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.\n   2. Monoclonal antibody treatment for MM within 21 days.\n   3. Cytotoxic therapy within 21 days.\n   4. PI therapy within 14 days.\n   5. Immunomodulatory agent therapy within 7 days.\n   6. Radiotherapy within 14 days or focal radiation within 7 days.\n   7. Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \\[CAR\\]-T cells) ≤12 weeks before the first dose of study drug\n2. Has received any of the following:\n\n   1. Packed red blood cells within the last 7 days prior to dosing\n   2. Platelet transfusions within the last 7 days prior to dosing\n   3. Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study\n3. History of Grade ≥3 CRS or ICANS with prior therapies.\n4. Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.\n5. Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:\n\n   a. Malignancies treated within the last 12 months and considered at very low risk for recurrence: i. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS).\n\n   ii. Skin cancer (non-melanoma or melanoma). iii. Noninvasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.\n\n   v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment).\n\n   b. Other malignancy that is considered at minimal risk of recurrence. In the event of any questions, consult with the Medical Monitor prior to enrolling a participant.\n6. Has active autoimmune disease or documented history autoimmune disease with exception of vitiligo, type I diabetes mellitus, or prior autoimmune thyroiditis currently euthyroid based on symptoms and labs.\n7. Has active plasma cell leukemia (≥20% peripheral blood plasma cells and ≥2.0×109\u002FL plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.\n8. Any of the following cardiac criteria currently or within the last 6 months:\n\n   1. Have documented major electrocardiogram (ECG) abnormalities which are clinically significant at the Investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle-branch blocks, ventricular hypertrophy, or recent myocardial infarction or a mean QTc of \\>470 ms \\[calculated using Fridericia's Correction, confirmed by triplicate ECG\\])\n   2. Cardiac function: left ventricular ejection fraction (LVEF) assessed by ECHO or MUGA \\\u003C45% (evaluation based on institutional lower limit of normal) and the patient has a significant cardiac history, or the investigator suspects ongoing cardiac pathology\n   3. Have the presence of cardiac disease, including a myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III-IV congestive heart failure, aneurysm of major vessels or heart, uncontrolled hypertension.\n   4. Overall cardiac ineligibility determined by the Investigator based on medical history and clinically indicated evaluations\n9. Any significant neurologic or psychiatric conditions diagnosed and\u002For ongoing in the last 6 months prior to anticipated treatment start date including but not limited to severe brain injury, stroke, intracranial hemorrhage, seizure, dementia, or Parkinson's disease. Participants with a history of uncontrolled epilepsy requiring anticonvulsants are excluded if therapy not stable within 6 months prior to enrollment.\n10. Active central nervous system (CNS) multiple myeloma involvement.\n11. Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.\n12. Has hepatitis B infection (i.e., HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status. See Section 7.4.7 for further required assessments.\n13. Has active hepatitis C infection as measured by positive HCV-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.\n14. Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 4 months after the last administration of study treatment.\n15. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.\n16. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n17. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.",{"count":5,"type":21},[109],"PHASE2","This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.",[27,112,58,113],"Multiple Myeloma Refractory","Multiple Myeloma",[113,115,116,117,118,119,120,121,122],"MM","RRMM","Relapsed multiple myeloma","Refractory multiple myeloma","Relapsed or refractory multiple myeloma","Elranatamab","Tocilizumab","T-cell engager","2026-08-10",{"date":89,"type":36},{"date":126,"type":21},"2026-08",{"date":128,"type":21},"2030-02",{"name":130,"class":43},"SCRI Development Innovations, LLC",5,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100650280","validating-dw-mri-and-fat-fraction-in-multiple-myeloma-post-asct-the-rac-fat-study-100650280","NCT07746232","Validating DW-MRI and Fat Fraction in Multiple Myeloma Post-ASCT: The RAC-FAT Study\"","Multicenter Observational Study for the Validation of the Predictive Role of Diffusion-Weighted Whole-body MRI (DW-MRI) Imaging Response According to MY-RADS Criteria (RAC Score) and Fat Fraction (rFF%) After Autologous Stem Cell Transplantation in Multiple Myeloma Patients Treated With First-Line Anti-CD38-Based Therapy (RAC-FAT Study)","Inclusion criteria:\n\n* Newly diagnosed MM participants eligible for ASCT, treated with anti-CD38-based quadruplet induction therapy and ASCT, with post-ASCT\u002Fpremaintenance DW-MRI available (in tandem ASCT, DW-MRI after second ASCT will be considered).\n* Age ≥18 years.\n* Participant must sign an informed consent form (ICF) that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.\n\nExclusion Criteria:\n\n\\- Absence of post-ASCT\u002Fpre-maintenance DW-MRI.",{"count":140,"type":21},92,"OBSERVATIONAL","This is a multicenter, observational, retrospective-prospective study designed to validate the predictive role of advanced imaging in patients with newly diagnosed multiple myeloma (NDMM). The main purpose of this study is to estimate the prevalence of radiological response categories (Response Assessment Category, RAC score) and evaluate the predictive value of relative Fat Fraction (rFF%) using Diffusion-Weighted Whole-Body Magnetic Resonance Imaging (DW-MRI) in patients who have undergone autologous stem cell transplantation (ASCT) after receiving first-line anti-CD38-based quadruplet induction therapy.",[27],[145,146,147,148,149,150,151,152],"Newly diagnosed multiple myeloma (NDMM)","Transplant-eligible (TE)","Diffusion-weighted whole-body MRI (DW-MRI)","MY-RADS criteria","Response Assessment Category (RAC score)","Fat Fraction (rFF%)","Autologous Stem Cell Transplantation (ASCT)","Anti-CD38-based therapy","2026-07-30",{"date":155,"type":36},"2026-08-04",{"date":126,"type":21},{"date":158,"type":21},"2030-08",{"name":160,"class":43},"Fondazione EMN Italy Onlus",10,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100649892","phase-3-a-study-comparing-treatment-with-teclistamab-and-talquetamab-versus-daratumumab-and-lenalidomide-in-patients-with-multiple-myeloma-after-stem-cell-transplant-who-still-have-detectable-disease-100649892","NCT07740486","A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease","Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)","TiTan","Inclusion Criteria:\n\n1. Documented diagnosis of MM as per IMWG diagnostic criteria.\n2. Newly diagnosed patients who have completed a single or tandem autologous stem cell transplant after receiving quadruplet induction (containing an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor). Up to 2 cycles of post-ASCT consolidation are acceptable.\n3. Patients must have received high-dose chemotherapy and a first ASCT within 12 months from the initiation of induction therapy.\n4. Patients must be within 6 months of their most recent ASCT, or within 7 months for patients who received consolidation therapy.\n5. Positive minimal residual disease (at a 10-⁵ threshold) in the bone marrow assessed by NGF after autologous stem cell transplantation (assessed 60 to 150 days after transplantation and after completion of any consolidation therapy, with the assessment used for eligibility performed prior randomization).\n6. Males or females ≥ 18 years of age\n7. Karnofsky performance status score ≥ 50% ( ECOG performance status score of ≤2).\n8. Adequate hepatic function, with bilirubin ≤ 2.0 x ULN - except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤ 1.5 ULN is required) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN.\n9. ANC ≥ 1.0 x 109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF or 14 days for pegylated-G-CSF), hemoglobin ≥ 8 g\u002FdL (without red blood cell transfusion in the prior 7 days; recombinant human erythropoietin use is permitted), Platelets ≥75×109\u002FL in patients in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥50×109\u002FL in patients in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test)\n10. Calculated creatinine clearance (by Cockcroft-Gault) ≥ 30 ml\u002Fmin or creatinine clearance measured by a 24-hour urine collection.\n11. Serum calcium corrected for albumin ≤ 14 mg\u002Fdl or free ionized calcium \\\u003C6.5 mg\u002FdL.\n12. Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU\u002FmL) prior to initiating treatment. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before the drugs are administered.\n13. Females of childbearing potential must agree to use a highly effective method of contraception (failure rate \\\u003C1% per year), preferably with low user dependency, throughout the study treatment period and for at least 6 months after the last dose of study treatment.\n14. Male participants must agree to use a condom during sexual intercourse with a pregnant woman or a woman of childbearing potential during study treatment and for at least 90 days after the last dose of study treatment. In addition, male participants must ensure that their partner of childbearing potential uses effective contraception, (failure rate \\\u003C1% per year), preferably with low user dependency, during the same period.\n15. Voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.0.\n2. COPD with a FEV1 \\\u003C50% of predicted normal. Note that FEV1 testing is required for participants with known or suspected of having COPD or asthma and participants must be excluded if FEV1 \\\u003C50% of predicted normal.\n3. Severe persistent asthma within the past 2 years (see Appendix x\\[DS2.1\\] \\[for severity of Asthma\\]), uncontrolled asthma of any classification. Note that FEV1 testing is required for participants known or suspected asthma and participants must be excluded if FEV1 \\\u003C50% of predicted normal.\n4. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.\n5. Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.\n6. Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma).\n7. Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy.\n8. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n   1. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS).\n   2. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n   3. Noninvasive cervical cancer\n   4. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (radical prostatectomy\u002Fradiation therapy\u002Ffocal treatment)\n   5. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (antihormonal therapy is permitted)\n   6. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the Sponsor\n9. Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.\n10. Presence of the following cardiac conditions:\n\n    1. New York Heart Association stage III or IV congestive heart failure\n    2. Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment\n    3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n    4. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities\n    5. History of severe non-ischemic cardiomyopathy\n11. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n\n    1. Acute diffuse infiltrative pulmonary disease\n    2. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy\n    3. History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing.\n    4. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status.\n    5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n    6. History of noncompliance with recommended medical treatments\n12. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug (daratumumab, lenalidomide, teclistamab or talquetamab) or its excipients (refer to the appropriate IBs and SmPCs) or analogues and study-required co-medication.\n13. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.\n14. Received a strong CYP3A4 inducer within 5 half-lives prior to the first dose of study treatment (Flockhart 2021).\n15. Plasmapheresis within 28 days prior to the first dose of study treatment.\n16. Participant had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.\n\n    NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate Sponsor representative and resolve any issues before enrolling a participant in the study.\n17. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy before the planned first dose of study treatment.\n18. Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or replicating vaccines approved or authorized for emergency use (eg, COVID-19) by local health authorities are allowed.\n19. HIV infection (positive, history, treatment for HIV).\n20. Hepatitis B infection (ie, HbsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.\n21. Active hepatitis C infection as measured by positive HCV-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.",{"count":171,"type":21},248,[173],"PHASE3","Multiple myeloma is a type of blood cancer that can come back even after effective treatment. After high-dose therapy and autologous stem cell transplantation (ASCT), some patients have no visible signs of disease, but small numbers of cancer cells may still remain in the body. This is called measurable residual disease (MRD). These remaining cells may lead to disease relapse.\n\nThe purpose of this study is to find out whether a new maintenance treatment can eliminate these remaining cancer cells more effectively than the current standard treatment. More effective maintenance therapy may help reduce the risk of disease progression and improve long-term outcomes for patients.\n\nThis study, called TiTan, is a phase III, multicenter clinical trial conducted in Poland. It will include 248 adult patients with newly diagnosed multiple myeloma who have undergone ASCT, have no signs of disease progression, but still have detectable MRD.\n\nParticipants will be randomly assigned (by chance) to one of two treatment groups. Neither the patient nor the doctor can choose the group.\n\nIn the experimental group, patients will receive two immunotherapy medicines, teclistamab and talquetamab. If MRD becomes undetectable after the protocol-defined period, treatment may be stopped and the patient will continue under observation.\n\nIn the standard treatment group, patients will receive daratumumab and lenalidomide, which are commonly used maintenance treatments. The duration and adjustments of treatment may depend on MRD results.\n\nThe main goal of the study is to determine how many patients achieve undetectable MRD after 12 months of treatment together with a complete response to therapy. This will show whether the new treatment is more effective in removing residual cancer cells.\n\nThe study will also evaluate how long patients live without disease progression, overall survival, treatment safety, and the impact of treatment on patients' daily functioning and quality of life. In addition, researchers will assess whether achieving undetectable MRD leads to better long-term outcomes.\n\nPatient safety will be closely monitored throughout the study. Participants will undergo regular medical check-ups, including blood tests, bone marrow tests, and imaging studies. All side effects will be carefully recorded and assessed according to international standards. Patients may withdraw from the study at any time without giving a reason.\n\nThis non-commercial study aims to improve knowledge about maintenance treatment in multiple myeloma after ASCT and may help support future treatment decisions for patients with this disease.",[27],[113,177,178,179,180,181],"Maintanance Therapy","Measurable residual disease","Autologous stem cell transplantation","Bispecific antibodies","Bone marrow disease assessment","2026-07-28",{"date":184,"type":36},"2026-07-31",{"date":186,"type":21},"2026-09",{"date":188,"type":21},"2033-04",{"name":190,"class":43},"Polish Myeloma Consortium",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100649825","neurocognitive-trajectories-after-bcma-car-t-100649825","NCT07740317","Neurocognitive Trajectories After BCMA CAR-T","Longitudinal Neurocognitive Trajectories After BCMA CAR-T in Multiple Myeloma","CAR-T Cog","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign an IRB-approved informed consent\n2. Ability to retain independent decision-making capacity as per the enrolling investigator\n3. Age ≥ 18 years of age at the time of consent\n4. Scheduled to receive BCMA CAR-T therapy for RRMM as confirmed by the treating clinician\n5. Ability to read and understand the English language\n6. ECOG 0-2\n7. If actively taking benzodiazepine, must be able to hold for 3 hours prior to study assessments as per treating clinician\n8. Reliable access to internet access; a tablet, laptop and\u002For desktop computer with a camera; or willingness to come into the clinic to conduct study procedures as outlined in the Study Calendar- as per participant self-report\n9. Ability to complete required assessments, as determined by the treating clinician\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) disease\n2. Known neurodegenerative disease or major neurocognitive disorder\n3. Stroke and\u002For traumatic brain injury (TBI) within 12 months\n4. Concurrent investigational neuroactive drugs",{"count":200,"type":21},50,"The purpose of this research study is to evaluate cognitive changes over time in participants with relapsed or refractory multiple myeloma who have received chimeric antigen receptor T-cell therapy (CAR-T).",[27,203,204],"CART Therapy","Refractory Multiple Myeloma (RRMM)",[206],"cancer",{"date":184,"type":36},{"date":186,"type":21},{"date":210,"type":21},"2029-11",{"name":212,"class":43},"Wake Forest University Health Sciences",1,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":213},"100625983","early-phase-1-a-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-qi-019a-in-patients-with-relapsedrefractory-multiple-myeloma-100625983","NCT07429721","A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019A in Patients With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years, any gender;\n* 2\\. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;\n* 3\\. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it, confirmed by available clinical evidence; or deemed by the investigator to be refractory to both immunomodulatory agents and proteasome inhibitors, with disease progression during the most recent anti-myeloma treatment or within 2 months after it (according to IMWG diagnostic criteria);\n* 4\\. Disease must be measurable at screening, meeting one or more of the following criteria:\n\n  * Serum M protein level ≥ 0.5 g\u002FdL;\n  * Or urine M protein level ≥ 200 mg\u002F24h;\n  * Or involved serum free light chain ≥ 10 mg\u002FdL with abnormal serum free light chain κ\u002Fλ ratio;\n* 5\\. ECOG performance status 0-2, with an expected survival of ≥ 3 months;\n* 6\\. Bone marrow function test results (from screening or within 2 months prior) meet the following requirements:\n\n  * Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin allowed; for patients meeting the ≥ 6 g\u002FdL hemoglobin requirement at screening, red blood cell transfusions are allowed to maintain hemoglobin ≥ 6 g\u002FdL;\n  * Absolute neutrophil count (ANC) ≥ 600\u002FμL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week before screening or pegylated G-CSF within 2 weeks before screening);\n  * Platelet count ≥ 50,000\u002FμL;\n  * Lymphocyte count ≥ 500\u002FμL;\n* 7\\. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL\u002Fmin;\n* 8\\. Liver function must meet the following criteria:\n\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× the upper limit of normal (ULN);\n  * Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0× ULN (except for congenital hyperbilirubinemia, e.g., Gilbert's syndrome, direct bilirubin ≤1.5× ULN);\n  * Albumin ≥3 g\u002FdL;\n* 9\\. Cardiac function must meet the following criteria:\n\n  * Left ventricular ejection fraction ≥50% (by echocardiography or MUGA scan);\n  * No clinically significant pericardial effusion;\n  * No clinically significant electrocardiogram abnormalities;\n* 10\\. Pulmonary function must meet the following criteria:\n\n  • Blood oxygen saturation ≥90% without oxygen supplementation;\n* 11\\. Women of childbearing potential must have a negative pregnancy test at screening and before drug infusion and must not be breastfeeding.\n* 12\\. Men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 1 year after the use of the study drug;\n* 13\\. Men and women of childbearing potential must agree not to donate sperm or eggs (oocytes) or other reproductive cells from the time of signing the informed consent until 1 year after the use of the study drug;\n* 14\\. The subject or their legal guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study.\n\nExclusion Criteria:\n\n* 1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):\n\n  * Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;\n  * Received immune\u002Fnon-immune-directed systemic therapy within 1 week;\n  * Received cytotoxic therapy within 2 weeks;\n  * Received proteasome inhibitors within 2 weeks;\n  * Received immunomodulatory therapy within 1 week.\n  * Received radiotherapy within 4 weeks (if the radiotherapy covered ≤5% of bone marrow reserve, the subject is eligible regardless of the radiotherapy end date);\n* 2\\. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;\n* 3\\. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease currently;\n* 4\\. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;\n* 5\\. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;\n* 6\\. Within 6 months before infusion, tested positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above the normal range; tested positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA levels above the normal range; tested positive for human immunodeficiency virus (HIV) antibody; or tested positive for syphilis;\n* 7\\. Had symptomatic heart failure or other serious cardiac diseases such as severe arrhythmias:\n\n  * New York Heart Association (NYHA) class III or IV congestive heart failure;\n  * Experienced myocardial infarction or underwent coronary artery bypass graft (CABG) or coronary stent implantation within 6 months prior to signing the ICF;\n  * Had clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal response or dehydration);\n  * Had a history of severe non-ischemic cardiomyopathy;\n* 8\\. Other clinically significant diseases, including:\n\n  * Primary immunodeficiency;\n  * Stroke or seizure within 6 months prior to screening;\n  * Clear clinical evidence of dementia or altered mental status;\n  * Parkinson's disease or Parkinsonian movement disorders or history thereof;\n* 9\\. Undergoing surgery within 2 weeks of administration or planned surgery within 2 weeks after administration, except for surgeries under local anesthesia;\n* 10\\. Administration of live attenuated vaccines within 1 month before dosing;\n* 11\\. Known severe allergic reaction to QI-019B or any of its formulation components;\n* 12\\. Known severe allergic reaction to tocilizumab;\n* 13\\. Unsuitable for establishing intravenous access;\n* 14\\. Other conditions deemed by the investigator to be unsuitable for participation in this study.",{"count":221,"type":21},24,[223],"EARLY_PHASE1","This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019A in patients with relapsed\u002Frefractory multiple myeloma.",[27],[227,228,62,229,230],"in vivo","multiple myeloma","CD19","CAR-T","2026-07-20",{"date":233,"type":36},"2026-07-22",{"date":235,"type":36},"2026-03-03",{"date":237,"type":21},"2029-06-01",{"name":239,"class":43},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":261},"100611124","moving-forward-with-myeloma-a-lifestyle-intervention-for-individuals-with-multiple-myeloma-100611124","NCT07236502","Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma","MFM","Inclusion Criteria:\n\n1. Adult (≥ 18 years)\n2. Diagnosed with MM at least one year prior to study enrollment\n3. Has access to a cell phone\n4. Be deemed \"clinically stable\" by their physician guided by the following:\n\n   1. no near-term changes in planned myeloma-directed therapy anticipated. (e.g., patient who is 3 months from autologous stem cell transplant just starting on maintenance lenalidomide is eligible since maintenance is planned therapy following transplant)\n   2. no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND\n   3. stable performance status (ECOG 0-2)\n5. No reports of severe pain \\> Grade 3 \\[defined by the NCI CTCAE as tumor, neurologic, bone, or other pain interfering with self-care ADLs (bathing, dressing, toileting, continence, feeding)\\].\n6. Able to participate in moderate PA and strength training per clinician approval and confirmed by participant\n7. Able to understand and willing to sign a written informed consent document\n8. English proficient for reading and writing\n\nExclusion Criteria:\n\n1. Individuals with \\\u003C6 months of life anticipated, coexistent amyloidosis, and\u002For receiving appetite stimulants will not be approached\n2. Fully adherent to the ACS nutrition and physical activity guidelines\n3. Currently pregnant or lactating, or anticipating pregnancy\n4. On another interventional clinical trial that precludes co-enrollment\n5. Psychiatric or other clinical conditions that preclude study compliance\n6. Other important medical or safety considerations at the discretion of the investigator(s) and\u002For approving clinician",{"count":248,"type":21},184,[24],"The purpose of this project is to evaluate the impact of a 16-week lifestyle program that promotes changes in eating and exercise patterns. The main questions the study will answer are:\n\nDo improvements in eating and exercise patterns lead to improved physical function, quality of life and blood biomarkers of biologial aging among individuals with multiple myeloma? Participants will complete study activities 3-4 times during the study.\n\n1. In-person assessment to measure physical function, height\u002Fweight, body composition, and includes a blood draw\n2. Surveys completed online or on paper at home",[27],[253],"Lifestyle Intervention",{"date":233,"type":36},{"date":256,"type":36},"2026-01-30",{"date":258,"type":21},"2030-02-28",{"name":260,"class":43},"Medical College of Wisconsin",2,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":275,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":213},"100600762","early-phase-1-an-open-label-single-arm-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-oriv508-injection-in-treating-relapsedrefractory-hematological-malignancies-100600762","NCT07101705","An Open-label, Single-arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of OriV508 Injection in Treating Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n1. Aged 18 - 75 years.\n2. ECOG scores 0-1.\n3. Expected survival time ≥ 12 weeks.\n4. Have a record of confirmed multiple myeloma (MM) according to IMWG criteria, or a record of histologically confirmed aggressive B-cell non-Hodgkin lymphoma (B-NHL). According to the definition of the 2022 World Health Organization (WHO) classification, the pathological types of aggressive B-NHL include: diffuse large B-cell lymphoma, not otherwise specified; diffuse large B-cell lymphoma\u002Fhigh-grade B-cell lymphoma with MYC and BCL2 rearrangements; high-grade B-cell lymphoma, not otherwise specified; primary mediastinal B-cell lymphoma; mantle cell lymphoma; grade 3b follicular lymphoma; large B-cell lymphoma transformed from indolent B-NHL.\n5. For MM subjects only: (1) Have received at least 2 lines of anti-tumor therapy, with each line of therapy undergoing at least one complete treatment cycle, and have experienced disease progression during or within 12 months after the last treatment; or be judged by the investigator as double-refractory to immunomodulators and proteasome inhibitors, and did not achieve a minimal response (MR) or better during the last treatment or experienced disease progression within 60 days after the end of treatment. (2) Have measurable lesions during the screening period, meeting any of the following criteria: (a) Serum M-protein ≥ 0.5 g\u002FdL; (b) Urine M-protein≥ 200 mg\u002F24h; (c) Involved free light chain (FLC) level ≥10 mg\u002FdL provided serum FLC ratio is abnormal; (d) Plasma cell percentage ≥30% detected by bone marrow aspirate\u002Fbiopsy; (e) Presence of at least one extramedullary lesion with a maximum diameter ≥ 2 cm.\n6. For aggressive B-NHL subjects only: (1) Have received at least 2 lines of anti-tumor therapy, and are refractory to the last line of therapy (at least 2 cycles) (best response is PD or SD) or have experienced disease progression after the end of treatment. Previous treatments must include standard treatment regimens with anti-CD20 monoclonal antibodies (except for subjects with CD20-negative tumors) and anthracyclines; (2) Have at least one measurable lesion during the screening period: lymph node lesions must have a longest diameter \\> 1.5 cm, and extranodal lesions must have a longest diameter \\> 1.0 cm.\n7. Hemogram meets the following requirements:\n\n   * Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week prior to screening, recombinant human erythropoietin is permitted);\n   * Absolute neutrophil count (ANC) ≥ 750 \u002FμL (no granulocyte colony-stimulating factor (G-CSF) used within 1 week prior to screening or no pegylated G-CSF used within 2 weeks prior to screening);\n   * Platelet count ≥ 50,000 \u002FμL;\n   * Lymphocyte count ≥ 500 \u002FμL.\n8. Renal function: Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease (MDRD) equation) ≥ 40 mL\u002Fmin\u002F1.73m2 (If the eGFR of an MM subject is \\\u003C 40 mL\u002Fmin\u002F1.73m2, the Investigator may decide whether to enroll based on clinical indications).\n9. Liver function: Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome or liver invasion by tumor, ALT and AST ≤ 5.0 × ULN and total bilirubin ≤ 3 × ULN are permitted).\n10. Cardiac function: Left ventricular ejection fraction ≥ 45%.\n11. Pulmonary function: Pulse oxygen saturation ≥ 92% without oxygen inhalation.\n12. Women with childbearing potential must have a negative blood pregnancy test and not be in the lactation period.\n13. Men and women with childbearing potential must agree to use effective contraceptive measures from the time of signing the informed consent form (ICF) until 1 year after the investigational drug administration.\n14. Men and women with childbearing potential must agree not to donate reproductive cells such as sperm or eggs (oocytes) from the time of signing the ICF until 1 year after the investigational drug administration.\n15. The participant or their legally authorized representative agrees to participate in this clinical trial and signs the ICF, indicating that he\u002Fshe understands the objective and procedures of this clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. The subject has received the following therapy prior to signing the ICF:\n\n   * Small molecule targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer;\n   * Immunosuppressive agent therapy (such as tacrolimus, mycophenolate mofetil, etc.) within 28 days;\n   * Monoclonal antibody treatment within 21 days;\n   * Cytotoxic therapy within 14 days;\n   * Proteasome inhibitor therapy within 14 days;\n   * Immunomodulator agent therapy within 7 days;\n   * Therapeutic dose of corticosteroids (defined as prednisone ≥ 20 mg\u002Fday or equivalent dose of other corticosteroids) within 72 hours, but physiological replacement dose, topical and inhaled corticosteroids are permitted;\n   * Radiotherapy within 28 days (only for subjects whose radiation field covers \\> 5% of bone marrow reserve).\n2. Received autologous hematopoietic stem cell transplantation within 24 weeks prior to signing the ICF.\n3. Received organ transplantation or allogeneic hematopoietic stem cell transplantation.\n4. Have other malignant tumors prior to screening, except for the following cases: malignant tumors that have received radical treatment and have no known active disease within 2 years prior to screening; or adequately treated non-melanoma skin cancer with no evidence of active disease.\n5. Previously treated with any viral therapy using vesicular stomatitis virus G (VSVG)-pseudotyped virus.\n6. Known active central nervous system involvement or clinical signs of meningeal involvement.\n7. Complicated with severe uncontrolled active infections (bacterial, viral, fungal, etc.).\n8. Have active autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or diseases requiring systemic application of immunosuppressive drugs.\n9. Have hereditary bleeding\u002Fcoagulation diseases, other diseases that may increase the risk of bleeding, etc.\n10. Have active deep vein thrombosis (cancer emboli or thrombus) or pulmonary embolism within 12 weeks prior to signing the ICF, but if the investigator judges that the thrombus has been clinically treated and has no risk of detachment, enrollment is permitted.\n11. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA titer exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.\n12. Complicated with symptomatic heart failure or other severe cardiac diseases such as arrhythmia:\n\n    * New York Heart Association (NYHA) class III or IV congestive heart failure;\n    * Myocardial infarction, coronary artery bypass grafting (CABG) or coronary stent implantation within 24 weeks prior to signing the ICF;\n    * Clinically significant ventricular arrhythmia, or history of unexplained syncope (except those caused by vasovagal or dehydration);\n    * Significant non-ischemic cardiomyopathy history.\n13. Have other clinically significant diseases, including:\n\n    * Primary immunodeficiency;\n    * Stroke or epileptic seizure within 24 weeks prior to signing the ICF;\n    * Obvious clinical evidence of dementia or mental status changes;\n    * History of Parkinson's disease or Parkinson-like movement disorders.\n14. Underwent surgery within 2 weeks prior to signing the ICF or plan to undergo surgery within 2 weeks after drug administration, except for surgery under local anesthesia.\n15. Used attenuated\u002Finactivated vaccines within 28 days prior to signing the ICF.\n16. Known severe allergic reaction to OriV508 or its formulation components.\n17. Known severe allergic reaction to tocilizumab.\n18. Inability to establish venous access.\n19. Other situations deemed unsuitable for participating in the study by the investigator.","75 Years",{"count":270,"type":21},40,[223],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of OriV508 injection for patients with relapsed\u002Frefractory hematological malignancies.",[27,274],"Non-Hodgkin Lymphoma (NHL)",[276,228,277,278],"BCMA\u002FCD19","Non-Hodgkin lymphoma","In vivo CAR-T",{"date":280,"type":36},"2026-07-21",{"date":282,"type":36},"2025-09-08",{"date":284,"type":21},"2028-08-01",{"name":239,"class":43},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":131},"100641948","phase-3-personalising-treatment-for-myeloma-patients-based-on-initial-response-to-nhs-treatment-and-their-overall-fitness-level-100641948","NCT07649525","Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level","iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma","iFIT","Eligibility criteria for registration:\n\nInclusion criteria for registration:\n\n1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.\n2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,\n3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,\n4. Aged 18 years or greater,\n5. Able to provide full informed consent, and\n6. Prepared to comply with pregnancy prevention plan.\n\nExclusion criteria for registration:\n\n1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),\n2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,\n3. Previous treatment for myeloma, except as specified in the protocol,\n4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or\n5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.\n\nAdditional eligibility criteria for randomisation into iFIT1\u002FiFIT2\u002FiFIT3 pathways, as follows:\n\nInclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Completed 6 cycles of DRd induction therapy after registering within the iFIT study,\n* Able to provide full informed consent, and\n* Prepared to comply with pregnancy prevention plan.\n\nInclusion criteria specific to randomisation pathways:\n\n* Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),\n* Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),\n* Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),\n* Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),\n* Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),\n* Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),\n* Categorised as FRAIL according to the IMWG frailty index (iFIT2), and\n* Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).\n\nExclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,\n* Received a stem cell transplant,\n* Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and\n* Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.\n\nExclusion criteria specific to randomisation pathways:\n\n* Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),\n* Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and\n* Further exclusion criteria related to safety of interventions (iFIT1).\n\nFull inclusion and exclusion criteria are listed in the protocol.",{"count":295,"type":21},1226,[173],"iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.",[27,299],"Plasma Cell Leukemia (PCL)",[301,302,303,304,305,306],"Myeloma","Platform adaptive design","Immunotherapy","Frailty","Personalised therapy","Biomarker-driven","2026-07-14",{"date":309,"type":36},"2026-07-15",{"date":311,"type":21},"2026-07",{"date":313,"type":21},"2037-06",{"name":315,"class":43},"University of Leeds",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":322,"sex":17,"minAge":323,"maxAge":4,"enrollmentInfo":324,"targetDuration":326,"studyType":141,"phases":4,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100647002","early-screening-for-multiple-myeloma-based-on-liquid-biopsy-cfdna-fragmentomics-100647002","NCT07684274","Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics","Inclusion Criteria:\n\n* Age over 40 years.\n* Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.\n* Voluntarily participating and signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Prior cancer diagnosis within the past 5 years, or history of any form of systemic cancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.).\n* History of organ transplantation, or allogeneic bone marrow or stem cell transplantation.\n* History of blood transfusion within 7 days prior to blood collection.\n* Poor compliance or potential interference with signing informed consent as judged by the investigator, or any other conditions rendering the subject unsuitable for the study.",true,"40 Years",{"count":325,"type":21},290,"5 Years","Study on Early Screening of Myeloma Based on Liquid Biopsy cfDNA Fragmentomics Technology. This study aims to construct and validate a set of machine learning models for the early screening of myeloma tailored to the Chinese population, based on plasma cfDNA fragmentomics features, to effectively distinguish myeloma patients from healthy individuals.",[27,329,330],"Smoldering Multiple Myeloma (SMM)","MGUS","2026-07-01",{"date":333,"type":36},"2026-07-06",{"date":335,"type":21},"2026-06-13",{"date":337,"type":21},"2027-12-31",{"name":339,"class":43},"The First Affiliated Hospital with Nanjing Medical University",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":213},"100646714","phase-1-sonrotoclax-and-bcma-bispecific-antibody-in-newly-diagnosed-systemic-al-amyloidosis-based-on-t1114-genetic-stratification-100646714","NCT07687004","Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification","A Phase Ib\u002FII, Non-Randomized, Biomarker-Stratified Umbrella Study of Chemotherapy-Free Strategies in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Status: Sonrotoclax and a BCMA\u002FCD3 Bispecific Antibody (AL-005)","AL-005","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form (ICF).\n* Age ≥18 years and ≤70 years.\n* Confirmed diagnosis of primary light-chain amyloidosis, according to the diagnostic and treatment guidelines for primary light-chain amyloidosis, 2021 revised edition.\n\n  1. Subjects entering the phase Ib dose-escalation stage must also have confirmed t(11;14) translocation by FISH or other genetic testing.\n\nNewly diagnosed systemic AL amyloidosis, with no prior systemic anti-tumor therapy for AL amyloidosis.\n\n* Measurable disease at screening, defined as:\n\n  a) Difference between involved and uninvolved serum free light chains (dFLC) \\>20 mg\u002FL.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤3.\n* Adequate hepatic function, defined as total bilirubin \\\u003C1.5 × upper limit of normal (ULN) (total bilirubin \\\u003C3 × ULN for patients with Gilbert syndrome), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 × ULN.\n* Adequate renal function, defined as creatinine clearance ≥30 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n* Baseline oxygen saturation \\>92% on room air.\n* Hematologic parameters within 7 days before the start of screening meeting the following criteria: absolute neutrophil count ≥1.0 × 10⁹\u002FL, hemoglobin ≥70 g\u002FL without whole blood or red blood cell transfusion within 7 days, and platelet count ≥70 × 10⁹\u002FL without whole blood transfusion, platelet transfusion, or thrombopoietin receptor agonist treatment within 7 days; or deemed suitable for enrollment by the investigator based on clinical judgment.\n* Women of non-childbearing potential are eligible. Female patients of childbearing potential must have a negative serum β-human chorionic gonadotropin or urine pregnancy test at screening.\n* Male patients, women of childbearing potential, and their partners must voluntarily use effective contraceptive measures, as judged by the investigator, during the treatment period.\n* Male patients must agree not to donate sperm from the initial screening period until 90 days after the last dose of study treatment.\n* Patients must be willing and able to complete study procedures and follow-up assessments.\n\nNote: Women of childbearing potential are defined as all women who have experienced menarche and are not postmenopausal and have not undergone surgical sterilization, such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Postmenopausal status is defined as amenorrhea for more than 12 consecutive months without another specified cause. Women using oral contraceptives or mechanical contraceptive methods, such as intrauterine devices, should be considered to be of childbearing potential.\n\nMale subjects, including those who have undergone vasectomy, must agree to use condoms during sexual intercourse with women of childbearing potential and must have no plan to father a child from the date of signing the ICF, throughout the period of study drug administration, and for 3 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Non-AL amyloidosis, including hereditary amyloidosis and other non-AL types of amyloidosis.\n* Diagnosis of symptomatic multiple myeloma, according to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma, 2022 revised edition. Patients whose diagnosis is based solely on a serum free light-chain ratio ≥100 are not excluded.\n* Peripheral neuropathy \\> grade 2 or painful neuropathy ≥ grade 2 at screening, regardless of whether the patient is currently receiving medication.\n* History of another malignancy, other than AL amyloidosis, within 5 years before randomization.\n* Known intolerance, allergy, or contraindication to the active ingredients of the BCMA\u002FCD3 bispecific antibody or sonrotoclax.\n* Unstable or active cardiovascular or cerebrovascular disease, meeting any of the following criteria:\n\n  1. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days before the first dose;\n  2. NT-proBNP \\>8500 ng\u002FL;\n  3. Congestive heart failure with hospitalization for cardiovascular disease within 4 weeks before randomization;\n  4. Heart failure judged by the investigator to be caused by ischemic heart disease, such as prior myocardial infarction with elevated cardiac enzymes and electrocardiographic changes, or uncorrected valvular disease, rather than AL amyloid cardiomyopathy;\n  5. History of sustained ventricular tachycardia or ventricular fibrillation, or history of atrioventricular (AV) node or sinoatrial (SA) node dysfunction requiring a pacemaker or implantable cardioverter-defibrillator (ICD) but without implantation. Patients with an implanted pacemaker or ICD may be enrolled;\n  6. Corrected QT interval using Fridericia's formula (QTcF) \\>500 msec. Patients with an implanted pacemaker may be enrolled regardless of the corrected QT interval result;\n  7. Supine systolic blood pressure \\\u003C90 mmHg;\n  8. Any other cardiovascular or cerebrovascular disease that, in the investigator's judgment, makes the subject unsuitable for participation in this study.\n\nKnown active human immunodeficiency virus (HIV) infection or HIV seropositivity.\n\n* Active hepatitis B or hepatitis C infection. Hepatitis serology testing is required at screening. If hepatitis B surface antigen is positive, a negative DNA polymerase chain reaction (PCR) result must be confirmed before enrollment. -For patients receiving anti-HBV therapy, a negative HBV DNA PCR result must be confirmed before enrollment. If hepatitis C antibody is positive, RNA PCR testing must be performed, and a negative result must be confirmed before enrollment.\n* Pregnant or breastfeeding women.\n* Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of study treatment.\n* Major surgery, such as surgery requiring general anesthesia, within 2 weeks before enrollment, incomplete recovery from prior surgery, or planned surgery during the study period. Kyphoplasty or vertebroplasty is not considered major surgery. Patients scheduled to undergo procedures under local anesthesia may participate in the study.\n* Receipt of a live attenuated vaccine within 4 weeks before the first dose of study treatment.\n* Any active severe psychiatric or psychological disorder, medical disease, or other symptom or condition that, in the investigator's judgment, may affect treatment, compliance, or the ability to provide informed consent.\n\nContraindication to any required concomitant medication or supportive care.\n\n* Any disease or complication that may interfere with study procedures.\n* Unwillingness or inability to comply with the protocol.","70 Years",{"count":200,"type":21},[55,109],"This study is a prospective, single-center, phase Ib\u002FII clinical trial designed to evaluate the tolerability of sonrotoclax plus dexamethasone in this phase Ib\u002FII umbrella study and to determine the recommended phase II dose (RP2D). It also aims to assess the safety and hematologic response rate of sonrotoclax plus dexamethasone in patients with newly diagnosed systemic light-chain amyloidosis (NDAL) harboring t(11;14), and of a BCMA\u002FCD3 bispecific antibody in patients with NDAL without t(11;14). In addition, this study seeks to explore a chemotherapy-free treatment strategy based on t(11;14)-guided genetic stratification.",[27],[354,355,356],"BCMA\u002FCD3 bispecific antibody","Sonrotoclax","t(11;14)","2026-06-30",{"date":359,"type":36},"2026-07-07",{"date":361,"type":21},"2026-08-01",{"date":363,"type":21},"2029-08-01",{"name":365,"class":43},"Institute of Hematology & Blood Diseases Hospital, China",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":213},"100639463","phase-2-cm336-plus-isatuximab-for-newly-diagnosed-multiple-myeloma-with-renal-impairment-100639463","NCT07585760","CM336 Plus Isatuximab for Newly Diagnosed Multiple Myeloma With Renal Impairment","A Prospective, Single-arm, Single-center, Phase II Study of BCMA\u002FCD3 Bispecific Antibody Combined With CD38 Monoclonal Antibody in Newly Diagnosed Multiple Myeloma Patients With Renal Impairment","CAREMM-012","Inclusion Criteria:\n\n1. Age 18 to 80 years.\n2. Newly diagnosed symptomatic multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) criteria. Patients who have received up to 1 cycle of prior anti-myeloma therapy, excluding immunotherapeutic agents, are allowed to enroll.\n3. Presence of measurable disease at diagnosis, meeting at least one of the following criteria:\n\n   A.Serum M-protein ≥ 1 g\u002FdL (\\> 10 g\u002FL) measured by serum protein electrophoresis (SPEP) (for IgA or IgD myeloma, quantitative IgA or IgD levels may be used instead); OR\n\n   B.Urine M-protein ≥ 200 mg\u002F24 hours; OR\n\n   C.If both serum and urine M-protein do not meet the above criteria, an abnormal serum free light chain (FLC) ratio (normal FLC ratio: 0.26 to 1.65) with an involved serum FLC level ≥ 100 mg\u002FL.\n4. Accompanied by myeloma-related renal impairment (RI), defined as an estimated glomerular filtration rate (eGFR) \\\u003C 40 mL\u002Fmin (calculated using the Modification of Diet in Renal Disease \\[MDRD\\] formula). The type of renal impairment must be restricted to cast nephropathy, which can be confirmed by renal biopsy or by the investigator's clinical judgment based on light chain proteinuria. If urine albumin accounts for more than 30% of the total urine protein, a renal biopsy is mandatory to confirm cast nephropathy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.\n6. Adequate major organ function, meeting the following criteria:\n\n   A. Hematological function:\n   1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL, and without receiving granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days, or pegylated G-CSF within 14 days prior to testing;\n   2. Hemoglobin ≥ 60 g\u002FL, and without receiving whole blood or red blood cell transfusions within 7 days prior to testing;\n   3. Platelet count ≥ 50 × 10\\^9\u002FL, and without receiving whole blood, platelet transfusions, or thrombopoietin receptor agonists (TPO-RAs) within 7 days prior to testing.\n\n   B. Hepatic function:\n\n   Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 × ULN, and total bilirubin ≤ 2 × ULN (subjects with a history of Gilbert's syndrome are eligible if direct bilirubin ≤ 2.0 × ULN).\n\n   C. Coagulation function:\n7. International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n8. No active concomitant malignancies or malignancies with an expected survival of less than 12 months.\n9. Willingness to participate in the study, good compliance, and ability to sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Diagnosis of smoldering multiple myeloma (SMM), monoclonal gammopathy of undetermined significance (MGUS), Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, amyloidosis, or secondary plasma cell leukemia.\n2. Central nervous system (CNS) involvement or clinical evidence of meningeal involvement.\n3. Severe and\u002For uncontrolled cardiac diseases, including: unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe and uncontrolled arrhythmias; or other cardiovascular\u002Fcerebrovascular diseases deemed unsuitable for study participation by the investigator.\n4. Presence of active infections, including: HIV positive; active Hepatitis B (HBV-DNA positive); active Hepatitis C (HCV-RNA positive); active or latent syphilis infection (Treponema pallidum antibody positive); active tuberculosis (active TB infection indicated by chest imaging or other relevant tests within the past 3 months or during the screening period); or other active infections deemed unsuitable for study participation by the investigator.\n5. Patients with concurrent malignancies; or severe concomitant diseases that, in the investigator's judgment, would severely compromise patient safety or interfere with study completion.\n6. Pregnant or lactating women.\n7. History of severe allergic reactions (Grade ≥ 3) or hypersensitivity to any components of the study drugs.\n8. Unable or unwilling to sign the informed consent form.\n9. Any other conditions that, in the opinion of the investigator, make the patient unsuitable for enrollment.","80 Years",{"count":376,"type":21},26,[109],"This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by renal impairment (\\[eGFR\\] \\\u003C 40 mL\u002Fmin). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.",[27,380],"Multiple Myeloma Light Chain Induced Renal Insufficiency",[354,382],"CM336",{"date":384,"type":36},"2026-07-02",{"date":386,"type":21},"2026-07-25",{"date":388,"type":21},"2028-12-30",{"name":365,"class":43},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":322,"sex":17,"minAge":18,"maxAge":374,"enrollmentInfo":397,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":213},"100642057","phase-1-gprc5d-targeted-petct-imaging-in-plasma-cell-disorders-100642057","NCT07660939","GPRC5D Targeted PET\u002FCT Imaging in Plasma Cell Disorders","A Single-Center, Phase I, Single-Arm Prospective Interventional Study of GPRC5D-Targeted PET\u002FCT Imaging in Patients With Multiple Myeloma and Other Plasma Cell Disorders","Inclusion Criteria:\n\n* Adults with confirmed or suspected plasma cell disorders, including multiple myeloma.\n* Healthy volunteers eligible for PET\u002FCT imaging may also be enrolled.\n* Availability of recent clinical laboratory results within 1 week prior to imaging, when applicable.\n* Ability to undergo PET\u002FCT imaging procedures.\n* Ability to understand the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n* History of other active malignant tumors, unless considered clinically insignificant by the investigator.\n* Pregnant or breastfeeding women.\n* Inability to understand study procedures or comply with imaging examinations.\n* Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or image interpretation.",{"count":200,"type":21},[55],"This is a prospective, single-center, single-arm Phase I study evaluating GPRC5D-targeted PET\u002FCT imaging in patients with plasma cell disorders, including multiple myeloma.\n\nParticipants will undergo GPRC5D-targeted PET\u002FCT, 18F-FDG PET\u002FCT, and 68Ga-BCMA PET\u002FCT within 5 days whenever feasible for head-to-head comparison of lesion detection and disease assessment.\n\nThe study aims to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET\u002FCT and to compare its imaging characteristics with currently available molecular imaging modalities in plasma cell disorders.",[401,27],"Plasma Cell Disorders",[403,404,63,405,228,406,407,408],"targeted imaging","molecular imaging","precise oncology","PET\u002FCT","nuclear medicine","precise diagnosis","2026-06-16",{"date":411,"type":36},"2026-06-22",{"date":413,"type":21},"2026-06-25",{"date":415,"type":21},"2027-05-25",{"name":417,"class":43},"Peking University First Hospital",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":322,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":213},"100642739","pet-enabled-dual-energy-ct-in-multiple-myeloma-100642739","NCT07646873","PET-Enabled Dual-Energy CT in Multiple Myeloma","PET-enabled Dual-energy CT for Oncological Applications","Inclusion Criteria:\n\nFor all research participants:\n\n* Adults (age ≥ 18 years old)\n* Ability to understand and willingness to sign an informed consent form\n* Ability to adhere to the study visit schedule and other protocol requirements.\n* Willing and able to fast for at least 6 hours before and for the duration of the scan\n* No strenuous exercise for 24 hours prior to being scanned\n* Willing to lie on the scanner bed for up to 60 minutes\n\nFor healthy volunteers only:\n\n• Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in bone marrow.\n\nFor cancer patients only:\n\n* Patients with multiple myeloma who are planned to receive CAR T-cell therapy with any FDA-approved product, including Idecel and Ciltacel. Patients with prior chemo-immunotherapy are permitted.\n* Able to undergo bone marrow aspirate\u002Fbiopsy procedure\n\nExclusion Criteria:\n\n* Self-reported history of dysphoria or anxiety in closed spaces\n* Body weight \\>240 kg due to limitations of the scanner bed\n* Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET\u002FCT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)\n* Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG\n* Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only. That is, PET scans are not performed as part of a patient's treatment plan (e.g. standard of care, therapeutic purposes, or clinical care) and the research study did not intend to provide therapeutic benefit to the patient.\n* Prisoners\n* Any condition that would prevent the understanding or rendering of informed consent.\n* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.",{"count":426,"type":21},45,[24],"This pilot study will evaluate a new imaging method called PET-enabled dual-energy CT for measuring bone and soft-tissue composition in bone marrow. The study will enroll adults with multiple myeloma who are scheduled to receive CAR T-cell therapy and healthy adult participants.\n\nAll participants will undergo research imaging with dynamic 18F-FDG PET\u002FCT and X-ray dual-energy CT. Participants with multiple myeloma will have imaging before CAR T-cell therapy and again after therapy. Healthy participants will have one imaging visit.\n\nThe main goal is to compare bone and soft-tissue fraction measurements from PET-enabled dual-energy CT with measurements from standard X-ray dual-energy CT. The study will also explore whether corrected PET measurements are associated with bone marrow measurable residual disease, treatment response, and CAR T-cell therapy toxicities in participants with multiple myeloma.\n\nThis study is not expected to provide direct medical benefit to participants. The information learned may help improve future PET\u002FCT imaging methods for cancer evaluation.",[27],[431,432,406,433,113],"PET-enabled dual-energy CT","Dual-energy CT","18F-FDG","2026-06-09",{"date":436,"type":36},"2026-06-15",{"date":311,"type":21},{"date":439,"type":21},"2030-11",{"name":441,"class":43},"University of California, Davis",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":458,"leadSponsor":460,"locationsCount":213},"100643266","early-phase-1-safety-and-efficacy-of-rn9101-in-the-treatment-of-relapsedrefractory-multiple-myeloma-100643266","NCT07628595","Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Phase 1 Clinical Study Evaluating the Safety and Efficacy of RN9101 in the Treatment of Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled in this study:\n\n  1. Age ≥18 years, either sex;\n  2. Diagnosis of multiple myeloma (MM) according to IMWG response criteria, with BCMA target antigen expression on MM cells confirmed by flow cytometry or bone marrow pathology and immunohistochemistry;\n  3. Received at least 2 prior lines of anti-multiple myeloma therapy, with each line containing at least one complete treatment cycle, and documented disease progression during or after the most recent anti-myeloma therapy based on assessment data;\n  4. Measurable disease at screening, defined as meeting at least one of the following criteria:\n\n     1. Serum M-protein ≥ 0.5 g\u002FdL;\n     2. Urine M-protein level ≥ 200 mg\u002F24 h;\n     3. Involved serum free light chain ≥ 10 mg\u002FdL with abnormal serum free light chain κ\u002Fλ ratio;\n     4. Clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Definite increase in existing plasmacytomas or bone lesions (sum of the products of perpendicular diameters \\[SPD\\] of measurable lesions increased by ≥50% with an absolute increase of ≥1 cm);\n  5. ECOG performance status of 0-2, with an estimated life expectancy of ≥3 months;\n  6. Bone marrow function test results (at screening or within 2 months prior to screening) meeting the following conditions:\n\n     1. Hemoglobin ≥ 6 g\u002FdL (no red blood cell transfusion within 1 week prior to screening), with recombinant human erythropoietin permitted; for patients meeting the hemoglobin ≥ 6 g\u002FdL enrollment criterion, red blood cell transfusions may be allowed to maintain hemoglobin ≥ 6 g\u002FdL;\n     2. Absolute neutrophil count (ANC) ≥ 600\u002FμL (no granulocyte colony-stimulating factor \\[G-CSF\\] used within 1 week prior to screening, or no pegylated G-CSF used within 2 weeks prior to screening);\n     3. Platelet count ≥ 50,000\u002FμL;\n     4. Lymphocyte count ≥ 500\u002FμL;\n     5. Absolute CD3-positive T-cell count ≥ 150\u002FμL;\n  7. Normal renal function during screening or within 2 months prior to screening: creatinine clearance (CrCl) (calculated by the Cockcroft-Gault formula) ≥ 45 mL\u002Fmin;\n  8. Hepatic function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN);\n     2. Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin may be ≤ 1.5 × ULN);\n     3. Albumin ≥ 3 g\u002FdL;\n  9. Cardiac function during screening or within 2 months prior to screening meeting the following conditions:\n\n     1. Left ventricular ejection fraction (LVEF) ≥ 40% (assessed by echocardiography or MUGA scan);\n     2. No clinically significant pericardial effusion;\n     3. No clinically significant electrocardiogram abnormalities;\n  10. Pulmonary function during screening or within 2 months prior to screening meeting the following conditions:\n\n      1. Oxygen saturation ≥ 90%;\n      2. No clinically significant pleural effusion;\n  11. For females of childbearing potential, a negative pregnancy test at screening and prior to dosing, and not currently breastfeeding;\n  12. Males and females of childbearing potential must agree to use effective contraception from the date of informed consent signing until 1 year after the end of study treatment;\n  13. Males and females of childbearing potential must agree not to donate gametes (including sperm or ova) from the date of informed consent signing until 1 year after the end of study treatment;\n  14. The subject or their legally authorized representative has signed the Informed Consent Form (ICF), indicating understanding of the study objectives and procedures, and voluntary participation in this study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from the study:\n\n  1. Received other anti-tumor therapy during the screening period (as determined primarily by the investigator):\n\n     1. Received targeted therapy, epigenetic therapy, other investigational drug therapy, or treatment involving invasive investigational medical devices within 5 half-lives;\n     2. Received systemic immunologic or non-immunologic therapy within 1 week;\n     3. Received cytotoxic therapy within 1 week;\n     4. Received proteasome inhibitor and immunomodulatory therapy within 2 weeks;\n     5. Received radiotherapy within 4 weeks (except if the radiation field involves ≤5% of bone marrow reserve, in which case there is no restriction on the time since completion of radiotherapy, and the subject may still be enrolled);\n  2. Received allogeneic hematopoietic stem cell transplantation within 6 months prior to dosing, or autologous hematopoietic stem cell transplantation within 3 months prior to dosing;\n  3. History of malignancy other than multiple myeloma prior to screening, except for the following: malignancies treated with curative intent and with no known active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease;\n  4. Previously received any therapy utilizing vesicular stomatitis virus glycoprotein (VSV-G) pseudotyped virus;\n  5. Presence of severe and uncontrolled infection during screening (including bacterial, viral, fungal, etc.);\n  6. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range detected within 6 months prior to infusion; positive hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range; positive human immunodeficiency virus (HIV) antibody; positive syphilis test;\n  7. Symptomatic heart failure or other cardiac diseases, such as severe arrhythmias:\n\n     1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n     2. Myocardial infarction within 6 months prior to informed consent signing, or prior coronary artery bypass grafting (CABG) or coronary artery stent implantation;\n     3. Clinically significant ventricular arrhythmias or history of unexplained syncope (excluding vasovagal or dehydration-induced syncope);\n     4. History of severe non-ischemic cardiomyopathy;\n  8. Other clinically significant diseases, including:\n\n     1. Primary immunodeficiency;\n     2. Stroke or seizure within 6 months prior to screening;\n     3. Definite clinical evidence of dementia or altered mental status;\n     4. Parkinson's disease, parkinsonian movement disorders, or relevant history;\n  9. Received surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after dosing (except for local anesthesia procedures);\n  10. Received live attenuated vaccines within 1 month prior to dosing;\n  11. Known severe allergic reaction to RN9101 or any of its formulation components;\n  12. Known severe allergic reaction to tocilizumab;\n  13. Patients unsuitable for intravenous infusion;\n  14. Other conditions deemed by the investigator as rendering the subject unsuitable for participation in this study.",{"count":450,"type":21},19,[223],"This is a single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RN9101 injection for patients with relapsed\u002Frefractory multiple myeloma.",[27],"2026-06-07",{"date":456,"type":36},"2026-06-10",{"date":331,"type":21},{"date":459,"type":21},"2028-11-01",{"name":339,"class":43},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":469,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":488,"locationsCount":489},"100591004","phase-2-frontline-t-cell-engager-vs-autologous-stem-cell-transplant-asct-and-measurable-residual-disease-mrd-guided-sequential-intensification-therapy-in-multiple-myeloma-100591004","NCT06974786","Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma","Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)","FASTER","Inclusion Criteria:\n\n1. Age \\>18 years with no upper age limit.\n2. Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available.\n3. Eligible for ASCT according to institutional policy as evaluated by investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A).\n5. Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR).\n6. Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis):\n\n   a. Serum monoclonal (M) protein ≥1.0 g\u002Fdl (≥0.5 g\u002Fdl if IgA, IgD, IgE or IgM MM).\n\n   b. ≥200 mg of M protein\u002F24h in the urine. c. Difference between affected and unaffected free light chain ≥10 mg\u002FdL with abnormal kappa to lambda ratio.\n7. Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identified from a high disease burden sample obtained as SoC and enabling MRD testing during screening phase.\n8. Have clinical laboratory values meeting the following criteria during the Screening Phase and also at start of administration of study treatment:\n\n   • Hemoglobin ≥8g\u002FdL without prior red blood cells (RBC) transfusion within 14 days before the laboratory test; recombinant human erythropoietin use is permitted\n\n   • Platelets ≥75,000\u002Fµl\n\n   • Absolute neutrophil count ≥1,000\u002Fµl (prior growth factor support is permitted but must be without support for 7 days for granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating Factor (GM-CSF) and for 14 days for pegylated G-CSF before screening lab test\n\n   • Aspartate aminotransferase and alanine aminotransferase ≤2.5 × upper limit of normal (ULN)\n   * Renal function: Creatinine clearance (CrCl) ≥40 mL\u002Fmin based on calculation using Cockcroft-Gault formula or measured by a 24-hour urine collection.\n   * Total bilirubin ≤2 × ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤3 × ULN is required)\n   * Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6.5 mg\u002FdL (≤1.6 mmol\u002FL)\n9. Achievement of at least PR to induction therapy, without prior progression of disease.\n10. Prior completion of standard of care mobilization and collection of stem cells (minimum 2 × 106 CD34+ cells\u002Fkg) without use of chemotherapy mobilization, any time prior to or during screening phase.\n11. A woman of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.\n12. A woman must be:\n\n    a. Not of childbearing potential, or b. Of childbearing potential and practicing true abstinence; or i. Have a sole partner who is vasectomized; or ii. Practicing ≥1 highly-effective, user-independent method of contraception (Appendix B) NOTE: Participant must agree to continue the above throughout the study and for 4 months after the last dose of study treatment. If a woman becomes of childbearing potential after start of the study the woman must comply with point (b) as described above.\n13. A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 4 months after receiving the last dose of study treatment.\n14. A man must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 90 days after receiving the last dose of study treatment. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.\n\n    NOTE: If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository), but his female partner is not required to use contraception.\n15. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study treatment.\n16. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n17. Must sign an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n18. All participants must agree to comply with and be enrolled in Revlimid Risk Evaluation and Mitigation Strategy (REMS) program.\n19. All participants must agree to comply with and be enrolled in elranatamab Risk Evaluation and Mitigation Strategy (REMS) program.\n20. All participants must meet institution-specific criteria for ASCT eligibility as assessed by the Investigator.\n\nExclusion Criteria:\n\n1. Diagnosis of primary light chain amyloidosis, POEMS, Waldenstrom's macroglobulinemia, plasma cell leukemia, or central nervous system (CNS) involvement by MM.\n2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the elranatamab Investigator's Brochure \\[IB\\] and appropriate package inserts).\n3. Prior or concurrent exposure to any of the following:\n\n   c. Any anti-BCMA therapy. d. Epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.\n\n   e. Investigational vaccine within 4 weeks. f. Live, attenuated vaccine within 4 weeks before randomization. g. Radiotherapy within 14 days. h. Gene-modified adoptive cell therapy (e.g., CAR modified T cells, NK cells). i. Cytotoxic therapy within 14 days.\n4. Minimum washout period for prior therapy:\n\n   1. PI therapy - 14 days.\n   2. IMiD agent therapy -14 days.\n   3. Anti CD38 monoclonal therapy - 14 days.\n   4. Corticosteroids - 7 days.\n5. Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole brain magnetic resonance imaging and lumbar cytology are required.\n6. Myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are:\n\n   a. Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.\n\n   b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n\n   c. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n\n   d. Localized prostate cancer (N0M0): i. With a Gleason score of ≤6, treated within the last 24 months, or untreated and under surveillance.\n\n1\\) With a Gleason score of 3+4 that has been treated \\>6 months prior to full study screening and considered to have a very low risk of recurrence, or e. History of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.\n\nf. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence (\\\u003C5% over 5 years).\n\ng. Other malignancy that is considered cured with minimal risk of recurrence. 7. Stroke or seizure within 6 months prior to signing ICF. 8. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \\\u003C50% of predicted normal.\n\n9\\. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.\n\n10\\. Prior allogeneic bone marrow, hematopoietic stem cell or solid organ transplant.\n\n11\\. Participant is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.\n\n12\\. Participant plans to father a child while enrolled in this study or within 90 days after the last dose of study treatment.\n\n13\\. Presence of the following cardiac conditions: h. New York Heart Association Class III or IV congestive heart failure i. Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomization j. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n\nk. History of severe non-ischemic cardiomyopathy. 14. Any of the following:\n\n1. History of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS)-related illness.\n2. Active or recent infection (including SARS-COV-2). Participants with prior or recent infection must have infection resolved for \\>21 days and no use of systemic anti-infective therapy for \\>28 days.\n3. Hepatitis B infection (i.e., hepatitis B surface antigen \\[HBsAg\\] or hepatitis B virus \\[HBV\\]-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.\n4. Active hepatitis C infection as measured by positive hepatitis C virus (HCV)-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 HCVRNA positive) completed antiviral therapy and has undetectable HCV-RNA for at least 12 weeks following the completion of therapy, the participant is eligible for the study.\n\n   15\\. Major surgery within 14 days prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.\n\nNOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the Investigator must consult with the appropriate Sponsor representative and resolve any issues before enrolling a participant in the study.\n\n16\\. Contraindication or intolerance to required supportive care medications in the absence of alternative options.\n\n17\\. Contraindication or intolerance to daratumumab or lenalidomide, or prior to toxicities to lenalidomide during induction requiring reduction of dose to \\\u003C10 mg\u002Fday.\n\n18\\. Significant neuropathy (Grades 3-4 or Grade 2 with pain). 19. History of Guillain-Barre Syndrome or variant. 20. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the Investigator would constitute a hazard for participating in this study, such as:\n\n1. Uncontrolled diabetes.\n2. Acute diffuse infiltrative pulmonary disease.\n3. 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.\n4. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status.\n5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n6. History of non-compliance with recommended medical treatments.","19 Years",{"count":53,"type":21},[109],"This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).",[474,27],"Multiple Myeloma, Newly Diagnosed",[115,476,477,478,479,122,120,480,481],"Newly diagnosed multiple myeloma","NDMM","MRD","ASCT","Daratumumab","Lenalidomide","2026-06-02",{"date":484,"type":36},"2026-06-04",{"date":486,"type":36},"2025-08-08",{"date":188,"type":21},{"name":130,"class":43},11,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100629662","phase-1-a-study-to-compare-the-pk-characteristics-safety-tolerability-and-immunogenicity-of-hlx15-sc-with-darzalex-faspro-in-combination-with-lenalidomide-and-dexamethasone-rd-in-transplant-ineligible-patients-with-newly-diagnosed-multiple-myeloma-100629662","NCT07477587","A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","A Randomized, Double-blind, Parallel-controlled Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Body mass index (BMI): 18.5 kg\u002Fm2 ≤ BMI \\\u003C 28 kg\u002Fm2.\n3. Subjects must participate voluntarily, understand the study, and sign the ICF.\n4. Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .\n5. Serum albumin ≥ 35 g\u002FL.\n6. Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.\n7. The patient's ECOG performance status must be 0 or 1 .\n8. Patient must have clinical laboratory values meeting the following criteria during the screening period:\n\n   1. Hemoglobin ≥ 7.5 g\u002FdL (≥ 5 mmol\u002FL; red blood cell \\[RBC\\] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed).\n   2. Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (use of granulocyte-colony stimulating factor \\[G-CSF\\] is allowed).\n   3. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).\n   4. Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST \\> ULN or ULN \\\u003C total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN \\\u003C total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin \\> 3 x ULN).\n   5. Measured creatinine clearance ≥ 40 mL\u002Fmin .\n   6. Corrected serum calcium \\\u003C 14 mg\u002FdL (\\\u003C 3.5 mmol\u002FL); or free ionized calcium \\\u003C 6.5 mg\u002FdL (\\\u003C 1.6 mmol\u002FL) .\n   7. Platelet count ≥ 70 × 109\u002FL for patients with plasma cells \\\u003C 50% of bone marrow nucleated cells; platelet count \\> 50 × 109\u002FL for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).\n9. Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   1. Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n      Not a woman of childbearing potential (WOCBP) or WOCBP: must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously from signed ICF to at least 140 days following the last dose of study products. This includes one highly effective contraceptive method with a failure rate of \\\u003C 1% per year (tubal ligation, intrauterine device, hormonal \\[birth control pills, injections, hormonal patches, vaginal rings or implants\\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.\n\n      The subjects also need to agree not to donate or cryopreservation eggs (ova, oocytes) from signed ICF to at least 140 days following the last dose of study products.\n   2. Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products:\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.\n\n   or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n\n   Agree not to donate or cryopreservation sperm.\n10. A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. 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 an early undetected pregnancy\n\nExclusion Criteria:\n\n1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.\n2. Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and\u002For an absolute plasma cell count of ≥ 2 x 109\u002FL) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n3. Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg\u002Fday for a maximum 4 days) of corticosteroids before randomization.\n4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.\n5. Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).\n6. Patient has clinical signs of meningeal involvement of MM.\n7. Patient has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \\[FEV1\\] \\\u003C 50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Patient with known or suspected COPD or asthma must have a FEV1 test during screening.\n8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).\n9. Patient is known to have active hepatitis B or C.\n\n   1. Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Patients with resolved infection (that is, 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 hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.\n\n      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   2. Patient is seropositive for hepatitis C must be screened using PCR measurement of hepatitis C virus (HCV) ribonucleic acid (RNA) levels. Those who are PCR positive will be excluded.\n10. Patient has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.\n11. Patient has clinically significant cardiac disease, including:\n\n    1. Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \\[NYHA\\] Class III-IV ).\n    2. Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities.\n    3. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) \\> 470 ms.\n12. Patient has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products.\n13. Patient has history of drug abuse or substance abuse one year prior to randomization. Patient is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder).\n14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes) while enrolled in this study or within 140 days after the last dose of study products.\n\n    Or patient is a man who plans to father a child and\u002For donate sperm while enrolled in this study or within 140 days after the last dose of study products.\n\n    Patient does not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence \\[such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.\\], withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.).\n15. Patient had radiation therapy within 14 days of randomization.\n16. Patient had plasmapheresis within 28 days of randomization.\n17. Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization.\n18. Patient had major surgery within 28 days before randomization or has not fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 28 days after the last dose of study treatment. Kyphoplasty is not considered major surgery.\n19. Patient in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long \\[5 half-lives \\> 3 months\\]) before randomization.\n20. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":498,"type":21},258,[55],"The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant.\n\nParticipants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).",[27],[503],"Transplant ineligible Patients with Newly Diagnosed Multiple Myeloma","2026-05-19",{"date":506,"type":36},"2026-05-22",{"date":508,"type":21},"2026-05-27",{"date":510,"type":21},"2028-02-22",{"name":512,"class":74},"Shanghai Henlius Biotech",81,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":522,"briefSummary":523,"conditions":524,"keywords":527,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":536,"locationsCount":213},"100636325","beam-mm----hydroxybutyrate-enhanced-adaptive-immunity-in-multiple-myeloma-100636325","NCT07564219","BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma","BEAM-MM","Inclusion Criteria:\n\n* Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody (e.g., Teclistamab, Elranatamab, Linvoseltamab).\n* Age ≥18 years on the day the informed consent is signed.\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis.\n* Significant short-term weight loss (\\>10% within the last 6 weeks).\n* ECOG Performance Status ≥2.\n* Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies).\n* Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy).\n* Very high tumor burden with high risk for tumor lysis syndrome, as determined by myeloma-specific markers or markedly elevated LDH (per the treating myeloma team).\n* Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.",{"count":426,"type":21},[24],"This study investigates whether raising blood levels of beta-hydroxybutyrate (BHB) - a natural molecule produced by the body during fasting or a low-carbohydrate diet - is safe and feasible and can improve the effectiveness of immunotherapy in patients with multiple myeloma, while remaining safe and well-tolerated. Patients will be randomly assigned to one of four intervention groups or a control group. The intervention groups will either follow a ketogenic diet (less than 10% of calories from carbohydrates) or receive oral supplementation with deltaG® Ketone Monoester Performance \\[(R)-3-hydroxybutyl (R)-3-hydroxybutyrate; CAS 1208313-97-6; TdeltaS Global, Inc., Oxford, UK\\], administered orally three times daily at either a low dose (13.5 g per serving, 40.5 g\u002Fday) or a high dose (25 g per serving, 75 g\u002Fday), in accordance with the FDA GRAS-approved dosing range. The control group will receive standard nutritional care. The study includes two parts: Part A enrolls patients receiving bispecific antibody treatment, and Part B enrolls patients receiving CAR-T cell therapy. Both dosing levels are applied in each part.",[27,525,526],"CAR T Cells","Bispecific Antibodies",[528,529],"Ketogenic Diet","beta-hydroxybutyrate (BHB)","2026-04-26",{"date":532,"type":36},"2026-05-04",{"date":256,"type":36},{"date":535,"type":21},"2028-12-31",{"name":537,"class":43},"Universitätsklinikum Hamburg-Eppendorf",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":322,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":561,"locationsCount":564},"100609418","integrative-multi-omics-analysis-to-predict-monoclonal-gammopathies-clinical-evolution-100609418","NCT07214324","Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution","PNRR-2022-1237","Inclusion Criteria:\n\n* Age \\>18 years\n* Male or female patients\n* Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines\n* Willing and able to provide written informed consent\n\nHEALTHY VOLUNTEERS (HV)\n\n* Age \\>60 years\n* Diagnosis of osteoarthritis (OA)\n* Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients:\n\n  * Active current infection\n  * Autoimmune disease\n  * Women of childbearing potential unable to exclude pregnancy\n  * Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition\n\nHealthy Volunteers:\n\n* Prior joint surgery or severe joint deformity\n* Recent trauma, osteonecrosis, or OA caused by prior\u002Fcurrent joint infection\n* Metabolic disorders\n* Previous or current cancer diagnosis\n* Autoimmune diseases (e.g., rheumatoid arthritis)",{"count":83,"type":21},"This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). By integrating genomic, transcriptomic, immunophenotypic, and oral microbiome analyses, the study seeks to characterize the biological mechanisms underlying the transition to symptomatic multiple myeloma (MM). The study also includes in vitro modeling to investigate bone damage and immune dysfunction. Healthy volunteers (HV) undergoing joint replacement surgery for osteoarthritis will serve as controls. The ultimate goal is to improve early risk stratification and support future preventive strategies through a multi-omics approach. There is a pressing need for new strategies to identify high-risk individuals based on biological rather than purely clinical parameters. This study proposes an integrative, multi-omics approach to investigate the transition from MGUS\u002FSMM to MM. By analyzing the immunome and oral microbiome alongside molecular profiling, the goal is to identify reliable biomarkers of progression. The resulting insights could be enable more accurate risk stratification and guide the design of future preventive clinical trials aimed at delaying or halting disease evolution.",[548,329,27],"Monoclonal Gammopathy of Undetermined Significance (MGUS)",[550,551,552,553,554],"plasma cells","multi-omics","biomarkers","bone marrow microenvironment","microbiome","2026-04-22",{"date":557,"type":36},"2026-04-23",{"date":559,"type":36},"2025-03-17",{"date":40,"type":21},{"name":562,"class":563},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",4,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":573,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":261},"100635001","benefits-of-a-6-month-individualized-hybrid-real-life-adapted-physical-activity-program-on-the-quality-of-life-of-patients-treated-for-multiple-myeloma-100635001","NCT07547007","Benefits of a 6-month, Individualized, Hybrid, \"Real-life\" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma","Benefits of a 6-month, Individualized, Hybrid, \"Real-life\" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma: a Multicenter Randomized Controlled Trial","BAPAMM","Inclusion Criteria:\n\n* newly diagnosed or relapse multiple myeloma, \\> 60 yo, not eligible to transplant\n* 1st to 4th line of treatment initiated during the last 3 months\n* receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months\n\nExclusion Criteria:\n\n* severe cardiac amyloidosis\n* absolute contraindication to physical activity\n* inability to comply with the protocol requirements\n* not french speaker\n* patient under guardianship or curatorship\n* pregnant or lactating women","61 Years",{"count":575,"type":21},86,[24],"The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are :\n\nDoes this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare \\[arm information\\] to see if \\[insert effects\\].\n\nParticipants will be randomised in 2 groups.\n\n* control group: patients will receive only advices about physical activities benefit\n* interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).",[27],[580,228,581],"physical activity","control group","2026-04-16",{"date":557,"type":36},{"date":585,"type":36},"2026-01-22",{"date":587,"type":21},"2028-07-30",{"name":589,"class":43},"Centre Hospitalier Metropole Savoie",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":599,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":213},"100634403","early-phase-1-a-clinical-study-to-evaluate-the-safety-and-preliminary-efficacy-of-qi-019b-in-patients-with-relapsedrefractory-multiple-myeloma-100634403","NCT07539233","A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Relapsed\u002FRefractory Multiple Myeloma.",{"count":221,"type":21},[223],"This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019B in patients with relapsed\u002Frefractory multiple myeloma.",[27],[62,229,230,227],"2026-04-13",{"date":602,"type":36},"2026-04-20",{"date":604,"type":21},"2026-04-15",{"date":363,"type":21},{"name":365,"class":43},{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":213},"100634235","phase-1-br101-in-patients-with-relapsedrefractory-multiple-myeloma-100634235","NCT07537049","BR101 in Patients With Relapsed\u002FRefractory Multiple Myeloma","An Open-Label, Single-Arm Clinical Study Evaluating the Safety and Efficacy of BR101 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and be expected to complete follow-up examinations and treatments as required by the study procedures.\n2. Aged 18 to 75 years (inclusive), with no gender restriction.\n3. ECOG performance status of 0 or 1, and expected survival time ≥ 12 weeks.\n4. Adequate organ function, with laboratory test results within the following criteria within 7 days prior to enrollment:\n\n1\\) Coagulation function:\n\n* Fibrinogen ≥ 1.0 g\u002FL;\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal (ULN);\n* Prothrombin time (PT) ≤ 1.5 × ULN. 2) Hepatic function:\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n* Serum total bilirubin ≤ 1.5 × ULN, unless the subject has a documented diagnosis of Gilbert's syndrome;\n* Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN may be enrolled.\n\n  3\\) Renal function:\n* Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula, see Appendix 16.3).\n\n  4\\) Hematopoietic function:\n* Hemoglobin ≥ 60 g\u002FL (no red blood cell \\[RBC\\] transfusion within 7 days prior to laboratory testing; use of recombinant human erythropoietin is permitted); Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL (prior growth factor support is allowed, but no such supportive therapy within 7 days prior to laboratory testing);\n* Platelet count ≥ 50 × 10⁹\u002FL (no transfusion support within 7 days prior to laboratory testing);\n* Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL;\n* T-cell count ≥ 0.15 × 10⁹\u002FL. 5) Cardiopulmonary function:\n* Left ventricular ejection fraction (LVEF) ≥ 45%;\n* Blood oxygen saturation ≥ 91%. 5. Female subjects of childbearing potential must have a negative pregnancy test during the screening period. All male and female subjects with reproductive potential must agree to use effective contraceptive methods from the signing of the informed consent form until at least 6 months after the completion of BR101 injection infusion, or until CAR-positive cells are undetectable by two consecutive flow cytometry assessments (whichever occurs later). Female subjects considered non-fertile (meeting at least one of the following criteria):\n* Status post hysterectomy or bilateral oophorectomy;\n* Medically confirmed ovarian failure;\n* Medically confirmed postmenopausal status (amenorrhea for at least 12 consecutive months in the absence of pathological or physiological causes).\n\n  6\\. Meet the following criteria for multiple myeloma (MM):\n  1. Subjects with a confirmed diagnosis of multiple myeloma according to the IMWG updated criteria (2016);\n  2. BCMA expression positive on the plasma cell membrane surface detected by immunohistochemistry (IHC) or flow cytometry in the subject's tumor specimen (bone marrow);\n  3. Meet one of the following laboratory criteria:\n\n     1. Serum M-protein: IgG-type M-protein ≥ 5 g\u002FL; or IgA-type M-protein ≥ 5 g\u002FL; or IgD-type M-protein above the normal reference range;\n     2. Urinary M-protein ≥ 200 mg\u002F24 h;\n     3. Serum free light chain ≥ 100 mg\u002FL with an abnormal serum κ\u002Fλ free light chain ratio;\n     4. If the patient has peripheral plasma cells, a plasma cell proportion \\\u003C 5% is eligible for enrollment.\n  4. Relapsed\u002Frefractory multiple myeloma, defined as meeting one or more of the following:\n\n     1. Received at least 3 lines of prior therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory drugs);\n     2. Documented disease progression during or within 12 months after the most recent anti-multiple myeloma therapy.\n\n        Exclusion Criteria:\n\n        1\\. History of malignancy within the past 5 years, excluding adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma), carcinoma in situ of the cervix, or thyroid cancer after radical resection.\n\n        2\\. Patients who have used or require long-term use of immunosuppressive agents (e.g., cyclosporine or systemic corticosteroids) within 2 weeks prior to enrollment; however, physiological replacement, intermittent, topical, and inhaled corticosteroids are permitted.\n\n        3\\. Major surgery performed within 2 weeks prior to enrollment, or surgery planned within 2 weeks after study treatment initiation (excluding subjects scheduled for local anesthesia-only procedures).\n\n        4\\. Subjects with current or past central nervous system (CNS) disorders, such as epilepsy, paralysis, aphasia, stroke, subarachnoid hemorrhage or other CNS hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n\n        5\\. Patients with suspected or documented central nervous system involvement by plasma cell neoplasm during screening.\n\n        6\\. Severe cardiac disease including, but not limited to, unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ II), or severe cardiac arrhythmia.\n\n        7\\. Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic, renal, or metabolic diseases requiring pharmacologic management.\n\n        8\\. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection; positive hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; positive syphilis test.\n\n        9\\. Subjects with uncontrolled active fungal, viral, bacterial, or other infections (persistent infection-related signs\u002Fsymptoms without improvement following appropriate antimicrobial therapy) or infections requiring intravenous antimicrobial therapy.\n\n        10\\. Non-hematologic toxicities from prior therapy that have not resolved to baseline or grade ≤ 1 per NCI-CTCAE version 5.0, excluding alopecia and grade 2 peripheral neuropathy.\n\n        11\\. Patients who received autologous hematopoietic stem cell transplantation within 12 weeks prior to study drug administration, or who have a history of allogeneic hematopoietic stem cell transplantation.\n\n        12\\. Prior treatment with in vivo or ex vivo CAR-T therapy or other genetically modified cell therapy prior to enrollment.\n\n        13\\. Prior BCMA-targeted therapy administered more than 3 years before enrollment, unless BCMA expression \\>30%.\n\n        14\\. Administration of a live attenuated vaccine within 1 month prior to study drug dosing.\n\n        15\\. Prior receipt of any of the following anti-tumor therapies:\n\n     a) Immune\u002Fnon-immune targeted systemic therapy within 7 days; b) Cytotoxic therapy within 7 days; c) Proteasome inhibitor and immunomodulatory agent therapy within 2 weeks; d) Radiation therapy within 4 weeks (excluding local radiation to myeloma-related bone lesions); e) Targeted therapy, epigenetic therapy, other investigational medicinal products, or therapy involving invasive investigational medical devices within 5 half-lives.\n\n  16\\. Known severe hypersensitivity to tocilizumab, BR101 Injection, or any of its excipients.\n\n  17\\. Any other conditions that, in the investigator's judgment, render the subject ineligible for enrollment.",{"count":161,"type":21},[55],"This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose, safety, pharmacokinetic profile following administration of BR101 injection, and preliminary efficacy in subjects with relapsed or refractory multiple myeloma.",[27],"2026-04-12",{"date":620,"type":36},"2026-04-17",{"date":622,"type":21},"2026-04-30",{"date":624,"type":21},"2029-04-30",{"name":626,"class":43},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":22,"phases":636,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":652},"100601210","phase-2-study-for-frail-patients-with-newly-diagnosed-multiple-myeloma-treated-with-daratumumab-with-teclistamab-or-talquetamab-100601210","NCT07107529","Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.","EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial","Inclusion Criteria:\n\n1. Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study\n2. Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria\n3. Measurable disease defined as M-protein in the serum (≥1 g\u002FdL) or serum free light chain assay ≥10 mg\u002FdL \\[≥100 mg\u002FL\\] and abnormal serum immunoglobulin kappa\u002Flambda FLC ratio\n4. Frail according to the Simplified IMWG frailty index\n5. Have clinical laboratory values meeting defined range\n6. Patients of childbearing potential must agree to use adequate\u002Fhighly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n1. Non-secretory MM or measurable disease by urine or plasmacytoma only\n2. Central nervous system involvement of myeloma\n3. Significant pulmonary dysfunction\n4. Stroke, transient ischemic attack, or seizure within 6 months of eligibility\n5. Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy\n6. HIV and Hepatitis infections\n7. Exclude for any of the following:\n\n   1. Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.\n   2. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.\n8. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility\n9. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)\n10. Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility\n11. Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to \\>40 mg dexamethasone within the 14 days prior to C1D1\n12. Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed\n13. Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing\n14. Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery\n15. Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device \\\u003C4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected\n16. Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study\n17. Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments",{"count":635,"type":21},150,[109],"This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab.\n\nThe main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).",[27],[145,640,641,642],"Frail patient","Talquetamab","Teclistamab","2026-04-10",{"date":604,"type":36},{"date":646,"type":36},"2025-12-12",{"date":648,"type":21},"2034-02",{"name":650,"class":651},"European Myeloma Network B.V.","NETWORK",29]