[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Polish Myeloma Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100650546","phase-2-comparing-lower-versus-standard-doses-of-belantamab-mafodotin-with-pomalidomide-and-dexamethasone-in-relapsed-or-refractory-multiple-myeloma-100650546",false,"NCT07748689","Comparing Lower Versus Standard Doses of Belantamab Mafodotin With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma.","Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy With Reduced Versus Standard Dose of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed\u002FRefractory Multiple Myeloma (REBEL)","REBEL","Inclusion Criteria:\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the REBEL study protocol.\n2. Male or female, 18 years or older (at the time consent is obtained).\n3. Have a confirmed diagnosis of MM as defined by the IMWG criteria.\n4. Eastern Cooperative Oncology Group performance status of 0-2.\n5. Have been previously treated with at least 1 prior line of MM therapy, including a lenalidomide-containing regimen (lenalidomide must have been administered for at least 2 consecutive cycles), and must have documented disease progression during or after their most recent therapy.\n6. Must have at least ONE aspect of measurable disease, defined as one the following:\n\n   1. Urine M-protein excretion ≥200 mg\u002F24 h, or\n   2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n   3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C0.26 or \\>1.65) only if the patient has no measurable urine or serum M spike.\n7. Have undergone autologous stem cell transplant (autoSCT) or are considered transplant ineligible. Participants with a history of autoSCT are eligible for study participation provided the following eligibility criteria are met:\n\n   1. AutoSCT was \\>100 days prior to the first dose of study medication\n   2. No active bacterial, viral, or fungal infection(s) present\n8. All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events v5.0) must be Grade ≤1 at the time of enrolment, except for alopecia and Grade ≤ 2 peripheral neuropathy.\n9. Compliance with contraceptive precautions in accordance with the protocol.\n10. Organ System Function - adequate organ system functions as defined by the laboratory assessments\n\n    * Hematologic:\n\n      * Absolute neutrophil count - ≥1.5× 10 9\u002FL (Without growth factor support for the past 14 days, excluding erythropoietin)\n      * Hemoglobin - ≥8.0 g\u002FdL\n      * Platelets - ≥75 × 10 9\u002FL\n    * Hepatic:\n\n      * Total bilirubin - ≤1.5 × ULN; (isolated bilirubin \\>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\\u003C35%)\n      * Alanine aminotransferase (ALT) - ≤2.5 × ULN\n    * Renal o eGFR ≥30 mL\u002Fmin\u002F1.73 m2 (as calculated by MDRD formula)\n\nExclusion Criteria:\n\n1. Active plasma cell leukemia, amyloidosis, POEMS syndrome, allogeneic SCT or currently active GvHD.\n2. Anti-MM therapy or use of an investigational drug within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; Prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.\n3. Plasmapheresis within 7 days prior to the first dose of study drug.\n4. Prior treatment with pomalidomide and belantamab mafodotin in any treatment line.\n5. Evidence of cardiovascular risk including: current clinically significant (CS) untreated arrhythmias (eg. CS ECG abnormalities, 2nd degree (Mobitz Type II) or 3rd degree AV block); history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; heart failure NYHA III or IV class; uncontrolled hypertension.\n6. Any major surgery within the last 4 weeks.\n7. Any other active malignancy, except the disease is medically stable for at least 2 years or not require active therapy other than hormonal.\n8. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin, drugs chemically related, or any of the components of the study treatment.\n9. Evidence of active mucosal or internal bleeding.\n10. Cirrhosis or current unstable liver or biliary disease assessed by Investigator. Stable non-cirrhotic chronic liver disease is acceptable if other entry criteria are met.\n11. Intolerance or contraindications to anti-viral prophylaxis.\n12. Active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.\n13. Known HIV infection, unless the participant can meet all of the following criteria:\n\n    1. Established ART for at least 4 weeks and HIV viral load \\\u003C 400 copies\u002FmL within Screening Period.\n    2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL.\n    3. No history of AIDS-defining opportunistic infections within the last 12 months. NOTE: consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and\u002For overlapping toxicities with belantamab mafodotin or other combination products as relevant.\n14. Positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months before the first dose of the study intervention, unless the participant can meet the following criteria:\n\n    1. RNA test negative.\n    2. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks.\n15. Participants with hepatitis B will be excluded unless the patient is:\n\n    1. HBcAb+, HBsAg- with undetectable HBV DNA at screening.\n    2. HBsAg+ at screening or within 3 months before first study dose, but has undetectable HBV DNA, and a highly effective antiviral treatment started at least 4 weeks prior to first dose of study intervention.\n16. Presence of active serious renal conditions (e.g., requiring dialysis or any other condition that could affect the participant's safety). Isolated proteinuria due to MM is acceptable if other criteria are fulfilled.\n17. Ongoing Grade 3 or higher peripheral neuropathy or neuropathic pain\n18. Active or history of venous thromboembolism within the past 3 months.\n19. Contraindications to anti-thrombotic prophylaxis.\n20. Current corneal disease except for mild punctate keratopathy.\n21. Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (also lab abnormalities) that could interfere with participant's safety, obtaining ICF or compliance to the study procedures.\n22. Pregnant or lactating female.","ALL","18 Years",{"count":20,"type":21},228,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma.\n\nParticipants will be randomly assigned to receive either a reduced dose or a standard dose of belantamab mafodotin in combination with pomalidomide and dexamethasone. The study will evaluate treatment response, side effects, and minimal residual disease (MRD), which is a measure of the number of myeloma cells that remain after treatment. The goal is to determine whether treatment can be optimized while maintaining disease control and reducing treatment-related toxicity.",[27],"Relapsed \u002F Refractory Multiple Myeloma",[29,30,31,32,33],"multiple myeloma","Relapsed\u002FRefractory Multiple Myeloma","Belantamab Mafodotin","MRD-Guided Therapy","Measurable Residual Disease","NOT_YET_RECRUITING","2026-07-31",{"date":37,"type":38},"2026-08-06","ACTUAL",{"date":40,"type":21},"2026-10",{"date":42,"type":21},"2033-03",{"name":44,"class":45},"Polish Myeloma Consortium","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"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":55,"type":21},248,[57],"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.",[60],"Multiple Myeloma (MM)",[62,63,64,65,66,67],"Multiple Myeloma","Maintanance Therapy","Measurable residual disease","Autologous stem cell transplantation","Bispecific antibodies","Bone marrow disease assessment","2026-07-28",{"date":35,"type":38},{"date":71,"type":21},"2026-09",{"date":73,"type":21},"2033-04",{"name":44,"class":45},""]