[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-refractory-multiple-myeloma-rrmm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-refractory-multiple-myeloma-rrmm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,73,99,124,152,175,198],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100627993","phase-1-a-trial-to-study-if-regn17372-in-combination-with-linvoseltamab-is-tolerable-for-adult-participants-with-relapsedrefractory-multiple-myeloma-100627993",false,"NCT07455851","A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed\u002FRefractory Multiple Myeloma","A FIH Phase 1\u002F2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed\u002FRefractory Multiple Myeloma","Key Inclusion Criteria:\n\n1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol\n2. ECOG performance status score ≤1\n3. Participants must have measurable disease for response assessment as described in the protocol\n4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol\n2. Participants who have known MM brain lesions or CNS involvement\n3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening\n4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and\u002For prior treatment with a BCMAxCD3 bispecific antibody (phase 2)\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.\n\nThe aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone.\n\nThe study is looking at:\n\n* What side effects may happen from taking REGN17372 with linvoseltamab\n* How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma\n* What is the best dose of REGN17372 when given with linvoseltamab\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)\n* If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)",[27],"Relapsed Refractory Multiple Myeloma (RRMM)",[29,30,31],"B-cell maturation antigen (BCMA)","Anti-CD3 monoclonal antibodies (mAbs)","G-protein-coupled receptor class C group 5 member D (GPRC5D)","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2026-03-26",{"date":40,"type":20},"2033-09-30",{"name":42,"class":43},"Regeneron Pharmaceuticals","INDUSTRY",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100622370","phase-2-a-phase-2-study-of-radiotherapy-induced-immune-priming-to-enhance-elranatamab-elra-in-relapsed-refractory-multiple-myeloma-rrmm-with-extramedullary-disease-emd-and-paramedullary-disease-pmd-prime-emd-pmd-100622370","NCT07382739","A Phase 2 Study of Radiotherapy-induced Immune Priming to Enhance Elranatamab (Elra) in Relapsed Refractory Multiple Myeloma (RRMM) With Extramedullary Disease (EMD) and Paramedullary Disease (PMD) \"PRIME-EMD-PMD\"","Inclusion Criteria\n\n* RRMM exposed to IMID, PI, anti-CD38 mAb, relapsed or refractory to at least one prior line of therapy (LOT), progressed on or after the last regimen:\n\n  1. Relapsed disease: progressive disease (PD) \\>60 days after cessation of prior therapy\n  2. Refractory disease: PD \\\u003C=60 days after cessation of prior therapy, \\\u003C25% reduction in paraprotein (monoclonal protein \\[M-protein\\] or serum free light chains \\[sFLC\\]) or measurements of EMD\u002FPMD\n* Diagnosis of relapsed or refractory multiple myeloma as indicated by progression by IMWG criteria\n* At least one locus of EMD or PMD present on imaging (either PET\u002FCT or magnetic resonance imaging \\[MRI\\]):\n* EMD: extramedullary plasmacytoma, not a contiguous extension from a bone lesion.\n* PMD: paraskeletal plasmacytoma, contiguous extension from a bone lesion At least one locus of EMD\u002FPMD that was not previously radiated and can be treated with radiation\n* Hematology (supportive care is allowed, including transfusions and granulocyte colony stimulating factor (G-CSF), if cytopenia is deemed secondary to myeloma disease burden):\n* Hemoglobin (Hgb) \\>=7g\u002FdL\n* Platelet\\>=50K\u002FuL\n* Absolute neutrophil count (ANC) \\>=0.75K\u002FuL\n* Chemistry:\n* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \\\u003C=2.5 x upper\n* limit of normal (ULN)\n* Total bilirubin (TBili) \\\u003C=1.5ULN (except for a known history of Gilbert syndrome)\n* Creatinine clearance (CrCL) \\>=30mL\u002Fmin\u002F1.73m2\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) \\\u003C=2, unless ECOG PS due to pain\u002Fmorbidity secondary to underlying myeloma disease, with the potential of improved ECOG PS to \\\u003C=2.\n* All participants must be either\n* Not of childbearing potential, or\n* Practicing at least 1 highly effective method of contraception until 6 months after the last dose of study treatment.\n* Childbearing age female participantsmust have a negative serum pregnancy test at screening and must agree to further pregnancy tests during the study.\n\nExclusion Criteria\n\n1. Prior or concurrent exposure to any of the following in the specified time frame prior to the first dose of Elra treatment:\n\n   * Within 14 days or at least 5 half-lives, whichever is less, of any investigational treatment\n   * Within 7 days of IMIDs, PI, anti-CD38 mAb, or cytotoxic systemic myeloma therapies\n   * Within 12 weeks of autologous stem-cell therapy (ASCT) or 6 months of AlloSCT and has to be off immunosuppressive agents \\>=42 days without signs of graft versus host disease (GVHD)\n   * Within 2 weeks of major surgery\n   * Within 6 months of cerebrovascular accident (CVA) events\n2. Waldenstrom, POEMS, Amyloidosis, ongoing plasma cell leukemia (PCL)\n3. History of Human Immunodeficiency Virus (HIV)\n4. Active, uncontrolled HBV infection despite antiviral therapy.\n5. Uncontrolled cardiac, pulmonary, gastrointestinal (GI), hepatic, renal, central nervous system(CNS) diseases not due to myeloma, at the discretion of investigator, that are not a candidate for T cell engager (TCE) therapy\n6. Uncontrolled or recurrent infections\n7. Autoimmune disease requiring systemic treatment (except for low dose steroids, equivalent to 10mg\u002Fday or less of prednisone)\n8. Disabling psychiatric conditions, substance abuse (alcohol, or drug), dementia, altered mental status\n9. Any other active malignancies within 5 years of completing treatment (with the exception of hormonal therapies for breast or prostate cancer) and \\>minimal risk of recurrence\n10. Myelodysplastic syndromes (MDS)\n11. Any issues that may impair the ability of the participant to receive or tolerate the planned treatment, to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that would prevent, limit, or confound the protocol specified assessments.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Elra or other agents used in study.\n13. History or possible non-compliance with recommended treatments",{"count":52,"type":20},34,[24],"To learn if low doses of radiation therapy can help the drug elranatamab enhance the killing effect of the cancer cells.",[56,57,58,27,59,60,61],"Phase 2","Radiotherapy-Induced Immune Priming","Elranatamab","Extramedullary Disease in Multiple Myeloma","Paramedullary Disease","PMD","2026-04-09",{"date":64,"type":36},"2026-04-14",{"date":66,"type":36},"2026-03-31",{"date":68,"type":20},"2030-12-31",{"name":70,"class":71},"M.D. Anderson Cancer Center","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100595458","phase-1-mezigdomide-and-talquetamab-in-relapsed-and-refractory-multiple-myeloma-100595458","NCT07032714","Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma","MAGENTA: Phase I Study of Mezigdomide and Talquetamab in Relapsed and Refractory Multiple Myeloma","MAGENTA","Inclusion Criteria:\n\n* Participant has given voluntary signed written informed consent before performance of any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix).\n* Age ≥ 18 years\n* Measurable disease of multiple myeloma as defined by at least one of the following:\n\n  * Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * ≥ 200 mg of monoclonal protein in the urine on 24-hour urine protein electrophoresis\n  * Serum free light chain (FLC) ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free light chain ratio\n* Previously treated relapsed and refractory multiple myeloma:\n\n  * Patients must have received at least three prior lines of therapy;\n  * Prior therapy including an immunomodulatory drug, proteasome inhibitor, and anti-CD38 antibody (either in separate regimens or within the same regimen); and\n  * Disease progression on, or within 60 days of completion of last therapy.\n* ANC ≥ 1000\u002FμL. G-CSF is not permitted within 14 days of screening.\n* Platelet count ≥ 50,000\u002FµL. Platelet transfusion and thrombopoietin receptor agonists are not permitted within 7 days of screening.\n* Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n* Calculated creatinine clearance of ≥ 30 mL\u002Fmin by Modified Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula\n* Serum bilirubin values \\\u003C 1.5 x ULN. Isolated bilirubin x 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (e.g. total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin); and\n* Serum aspartate transaminase (ALT) and aspartate transaminase (AST) values \\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range.\n* Must be able to comply with thromboembolism prophylaxis with e.g. acetylsalicylic acid (ASA), apixaban, rivaroxaban, lower molecular weight heparin, or equivalent.\n* Females of childbearing potential (FCBP) must:\n\n  * Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy. The subject must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.\n  * Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by the Pregnancy Prevention Plan.\n* Male subjects must follow the mezigdomide Pregnancy Prevention Plan (see Appendix).\n* Agree to follow the lifestyle considerations in Section 3.4 regarding blood donation, hospitalization and being in proximity to the hospital, and driving or operating heavy machinery.\n\nExclusion Criteria:\n\n* Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.\n* Participants who are receiving any investigational agents.\n* Prior therapy with mezigdomide or iberdomide.\n* Prior therapy with anti-GPRC5D therapy (e.g. talquetamab).\n* Prior therapy with bispecific antibody therapy within three months\n* Prior therapy with gene-modified adoptive cell therapy (e.g. CAR T-cells, NK cells) within three months\n* Plasmapheresis within seven days prior to start of study treatment.\n* Primary refractory disease.\n* Concomitant high dose corticosteroids. Low dose corticosteroids (maximum dose prednisone 10 mg\u002Fday or equivalent) are permitted if given for disorders other than myeloma, e.g. adrenal insufficiency, rheumatoid arthritis, etc.",{"count":82,"type":20},25,[23],"This is a phase 1 study to find the recommended dose and schedule of mezigdomide and talquetamab in relapsed and refractory multiple myeloma (RRMM), and to test the effects of the drugs on cancer. Cohort A will receive talquetamab + dexamethasone, then mezigdomide + talquetamab,+ dexamethasone. After Cohort A, Cohort B will evaluate mezigdomide + dexamethasone followed by step-up dosing of talquetamab (mezigdomide + talquetamab,+ dexamethasone).",[27],[27,87,88],"Prior therapy","Triple class exposed RRMM","2026-04-07",{"date":91,"type":36},"2026-04-13",{"date":93,"type":36},"2025-12-19",{"date":95,"type":20},"2028-07-01",{"name":97,"class":71},"Massachusetts General Hospital",3,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":98},"100580097","phase-2-elisa-in-relapsedrefractory-mm-100580097","NCT06832865","ELISA in Relapsed\u002FRefractory MM","A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\n* 1\\. This study will enroll patients with relapsed and refractory multiple myeloma who have had at least 2 prior lines of therapy including patients who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). Prior therapy with anti-CD38 and anti-B cell maturation antigen (BCMA) target will be permitted except an anti-BCMA T cell engager. Patients cannot be refractory to an anti-CD38 antibody.\n* 2\\. Measurable disease of multiple myeloma as defined by at least one of the following:\n\n  * a. Serum monoclonal protein ≥ 0.5 g\u002FdL. Patients with IgD disease and lower amounts of monoclonal protein may be permitted to enroll with PI approval\n  * b. ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * c. Serum free light chain ≥ 100 mg\u002FL (10 mg\u002FdL) and abnormal serum free kappa to serum free lambda light chain (FLC) ratio (\\\u003C0.26 or \\>1.65)\n* 3\\. Age ≥18 years.\n\n  --a. The effects of elranatamab and isatuximab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 4 months after the last dose of elranatamab and 5 months after the last dose of isatuximab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* 4\\. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* 5\\. Participants must have adequate organ and marrow function as defined below:\n\n  * a. ANC ≥ 1000\u002FμL. G-CSF is not permitted within 7 days of screening.\n  * b. Platelet count ≥ 50,000\u002FµL. Platelet transfusion is not permitted within 7 days of screening.\n  * c. Hemoglobin ≥ 8 g\u002FdL. Red blood cell transfusions are permitted to meet eligibility criteria.\n  * d. Calculated creatinine clearance of ≥ 30 mL\u002Fmin by Cockcroft-Gault equation.\n  * e. Patient has adequate hepatic function, as evidenced by each of the following:\n\n    * Serum bilirubin values \\\u003C 2 mg\u002FdL; and\n    * Serum aspartate transaminase (ALT) and\u002For aspartate transaminase (AST) values\\\u003C 2.5 × the upper limit of normal (ULN) of the institutional laboratory reference range. Patients with elevated bilirubin due to Gilbert's syndrome may be permitted with PI approval (i.e., total bilirubin \\\u003C3 mg\u002FdL and normal direct bilirubin).\n* 6\\. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* 7\\. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* 8\\. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* 1\\. Patients with active plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.\n* 2\\. Stem cell transplant within 12 weeks prior to enrollment, or active GVHD.\n* 3\\. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.\n* 4\\. History of any grade peripheral sensory or motor neuropathy with prior BCMA directed therapy. History of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.\n* 5\\. Previous treatment with an anti-BCMA bispecific T cell engager.\n\n  --a. Prior treatment with anti-BCMA CAR-T and\u002For ADC therapy is permitted; however, the participant cannot be refractory to this therapy if it was administered as the last line prior to study enrollment.\n* 6\\. Participants who are receiving any investigational agents currently.\n* 7\\. Participants who have had myeloma therapy or investigational drug within 2 weeks prior to start of treatment or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.\n* 8\\. Known or suspected hypersensitivity to the study drug or any components of the device (e.g. adhesive which contains acrylic).\n* 9\\. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:\n\n  * a. Acute myocardial infarction, acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, pericardial effusion);\n  * b. Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * c. Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\] or pulmonary embolism);\n* 10\\. Participants with known active HBV, HCV, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment. Per institutional protocol, HBV DNA testing by PCR is mandatory for subjects at risk for HBV reactivation.\n* 11\\. Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ and or other cancers treated with curative intent.\n* 12\\. Other surgical (including major surgery within past 14 days prior to enrollment) medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* 13\\. Live attenuated vaccine within 30 days of the first dose of study intervention.",{"count":107,"type":20},30,[24],"This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.",[27,111],"Relapsed Refractory Multiple Myeloma",[113,114,115],"Prior lines of therapy","relapsed and refractory multiple myeloma","RRMM","2026-03-11",{"date":118,"type":36},"2026-03-12",{"date":120,"type":36},"2025-08-14",{"date":122,"type":20},"2028-12-01",{"name":97,"class":71},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},"100495350","phase-3-a-trial-to-learn-how-well-linvoseltamab-works-compared-to-the-combination-of-elotuzumab-pomalidomide-and-dexamethasone-for-adult-participants-with-relapsedrefractory-multiple-myeloma-100495350","NCT05730036","A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed\u002FRefractory Multiple Myeloma","An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed\u002FRefractory Multiple Myeloma (LINKER-MM3)","LINKER-MM3","Key Inclusion Criteria:\n\n1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.\n3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.\n\n   Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.\n4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol\n5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium\n6. Life expectancy of at least 6 months\n\nKey Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n2. Prior treatment with elotuzumab and\u002For pomalidomide\n3. Participants with known MM brain lesions or meningeal involvement\n4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter\n5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.\n6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.\n7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).\n8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug\n9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \\\u003C40%.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":133,"type":20},410,[135],"PHASE3","This study is researching an experimental drug called linvoseltamab, also called REGN5458.\n\nLinvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).\n\nThis study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.\n\nThis study is looking at several other research questions, including:\n\n* How long participants benefit from receiving linvoseltamab compared with EPd\n* How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much\n* What side effects happen from taking linvoseltamab compared to EPd\n* How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd\n* If there is any improvement in pain after treatment with linvoseltamab compared to EPd",[27],[139,140,141,142],"BCMA X CD3 Bispecific Monoclonal Antibody","CD38 antibody","Proteasome inhibitor","Lenalidomide","2026-03-05",{"date":145,"type":36},"2026-03-06",{"date":147,"type":36},"2023-09-18",{"date":149,"type":20},"2033-04-19",{"name":42,"class":43},159,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100624236","phase-1-bcmacd3-bispecific-antibody-as-bridging-therapy-before-car-t-cell-infusion-in-rrmm-100624236","NCT07407010","BCMA\u002FCD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM","A Prospective Single-Arm, Single-Center Study of BCMA\u002FCD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in Relapsed or Refractory Multiple Myeloma","CM336-001","Inclusion Criteria:\n\n* 1.Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).2.Age ≥18 years.3.Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).4.Relapsed\u002FRefractory MM (RRMM) meeting one of the following:Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.Secondary plasma cell leukemia (sPCL):MM diagnosis per Chinese Guidelines (2022), plusPeripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells \\>2×10⁹\u002FL.5.Successful apheresis for CAR-T cell manufacturing.6.ECOG performance status ≤3.7.No active infections:HBV-DNA negative, HCV-RNA negative, HIV negative.8.Liver function:Total bilirubin \\\u003C1.5×ULN (\\\u003C3×ULN for Gilbert's syndrome).AST\u002FALT \\\u003C3×ULN.9.Renal function: Calculated CrCl ≥30 mL\u002Fmin (Cockcroft-Gault formula).10.Baseline oxygen saturation \\>92% (room air).11.Hematologic criteria (within 7 days of screening):WBC ≥1.0×10⁹\u002FL, ANC ≥1.0×10⁹\u002FL, hemoglobin ≥70 g\u002FL, andPlatelets ≥75×10⁹\u002FL (or ≥50×10⁹\u002FL if bone marrow plasma cells ≥50%).Investigator discretion permitted for clinical justification.12.Growth factor restrictions:2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).13.Reproductive requirements:Non-childbearing women eligible;Childbearing potential women: Negative serum\u002Furine pregnancy test (β-hCG) at screening.14.Contraception:Males\u002Ffemales of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.16.Compliance: Willing and able to complete study procedures and follow-up.\n\nExclusion Criteria:\n\n* 1.Prior GPRC5D-targeted immunotherapy.2.Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).3.Grade \\>2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).4.Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.5.Initiation of bridging therapy for BCMA CAR-T cell treatment.6.Unstable\u002Factive cardiovascular or cerebrovascular disease, including any of:a. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.b. Uncontrolled hypertension (\\>140\u002F90 mmHg with historical readings \\>180\u002F100 mmHg within 6 months).c. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB\u002FRBBB).d. LVEF \\\u003C40% by echocardiography.e. Stroke or intracranial hemorrhage within 12 months before screening.f. Pre-treatment severe thrombotic events.7.Active HIV infection or seropositivity.8.Active HBV\u002FHCV infection:HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).HCV: HCV Ab(+) requires negative HCV-RNA PCR.9.Pregnancy or lactation.10.Active gastrointestinal disorders affecting swallowing or drug absorption.11.Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty\u002Fvertebroplasty; allowed: local anesthesia procedures).12.Live vaccines within 4 weeks before first study dose.13.Active psychiatric\u002Fmedical conditions impairing compliance\u002Fconsent capacity per investigator judgment.14.Contraindications to required concomitant medications\u002Fsupportive care.15.Any condition interfering with study procedures.16.Inability\u002Funwillingness to comply with protocol.",{"count":161,"type":20},10,[23],"This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA\u002FCD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed\u002Frefractory multiple myeloma (RRMM).",[27],"NOT_YET_RECRUITING","2026-02-06",{"date":168,"type":36},"2026-02-12",{"date":170,"type":20},"2026-06-01",{"date":172,"type":20},"2028-05-31",{"name":174,"class":71},"Institute of Hematology & Blood Diseases Hospital, China",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":183,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":72},"100586812","phase-2-phase-ii-trials-of-letermovir-prophylaxis-in-patients-with-rrmm-undergoing-elranatamab-therapy-100586812","NCT06920251","Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy","Optimal Infection Prophylaxis Strategy for Relapsed\u002FRefractory Multiple Myeloma Patients Undergoing Elranatamab Therapy","OPTIMUS-EL","Inclusion Criteria:\n\n* Subjects must satisfy the following criteria to be enrolled in the study:\n\n  * Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF).\n\n    * Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n\n      * Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n\n        ④ Subjects have documented seropositivity for CMV (CMV IgG seropositvity) at any point. CMV IgG status will be re-checked during screening.\n\n        ⑤ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g\u002FdL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg\u002F24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n        \\*Patients with extramedullary disease (EMD) only will be allowed to participate if there is a measurable extramedullary lesion. These patients require PET-CT follow-up for response evaluation.\n\n        ⑥ Subject has received 3 or more prior lines of antimyeloma therapy. (Note: One line can contain several phases \\[e.g., induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and\u002For (with or without) maintenance therapy).\n\n        ⑦ Subject must have received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody.\n        * Subject must have documented disease progression during or after their last antimyeloma regimen.\n\n          * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.\n\n            * Individual of childbearing potential (IOCBP) must:\n\nA. Have two negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n\nB. Either commit to true abstinence\\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 90 days after the last dose of letermovir or 4 months after the last dose of elranatamab, whichever is longer.\n\n⑪ Male subjects must: A. Practice true abstinence\\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant individual or an individual of childbearing potential while participating in the study, during dose interruptions and for at least 90 days after the last dose of letermovir, even if he has undergone a successful vasectomy.\n\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. \\[Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n\n  * Male subjects must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of letermovir.\n\n    * Females must agree to refrain from donating eggs while on study treatment and for at least 90 days after last dose of letermovir.\n\n      * Subjects must agree to refrain from receiving live vaccines while on study treatment, during dose interruptions and for at least 90 days following the last dose of elranatamab.\n\nExclusion Criteria:\n\n* The presence of any of the following will exclude a subject from enrollment:\n\n  1. Subject who has a history of CMV end-oragn disease within 6 months prior to enrollment.\n  2. Subject who has evidence of CMV viremia at screening (D-7 CMV DNA results required - for specifics refer to section 5.3 and schedule of activities; SoA).\n  3. Subject who has received within 7 days prior to screening or plans to receive during the study ant of the following:\n\n     A. Ganciclovir B. Valganciclovir C. Foscarnet D. Acyclovir, at doses \\> 3200mg PO per day or \\> 25mg\u002Fkg IV per day E. Valacyclovir, at doses \\> 3000mg PO per day F. Famciclovir, at doses \\> 1500mg PO per day\n  4. Subject who has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.\n  5. Subject has received any of the following. A. Plasmapheresis within the last 28 days of initiating study treatment B. Major surgery (as defined by the investigator) within 28 days of initiating study treatment.\n  6. Subject has previously received allogeneic stem cell transplantation within a year during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study treatment. Patients who received allogeneic stem cell transplantation should not have evidence of active graft-versus-host disease (GVHD) and off any immunosuppressants.\n  7. Subject has plasma cell leukemia defined by IMWG definition for primary plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant light-chain amyloidosis.\n  8. Subject with known central nervous system (CNS) involvement with myeloma.\n  9. Subject has any significant medical condition, including active or uncontrolled infection, presence of laboratory abnormality, or psychiatric illness that places the subject at an unacceptable risk for treatment-related complications, if he\u002Fshe were to participate in the study.\n  10. Coronavirus disease 2019 (COVID-19) within 7 days for mild or asymptomatic infections or 14 days for moderate\u002Fsevere infections prior to initiating study intervention. A longer duration may be needed based on the investigator's clinical judgment.\n\n      A. Acute symptoms must have resolved and there are no sequelae that would place the participant at a higher risk of receiving study intervention, based on investigator assessment. No repeat\u002Ffollow-up COVID-19 testing is required.\n  11. Subject has any condition that confounds the ability to interpret data from the study.\n  12. Subject has any of the following laboratory abnormalities:\n\n      A. Absolute neutrophil count (ANC) \\\u003C 1,000\u002FµL. B. Platelet count \\\u003C 25,000\u002FµL. C. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin or requiring dialysis. eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) formula.\n\n      D. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN) E. Serum total bilirubin \\> 1.5 × ULN, or for participants with documented Gilbert's syndrome \\> 3.0 mg\u002FdL\n  13. Subject with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly alter the absorption of letermovir and\u002For other oral study treatment.\n  14. Subject has a prior history of malignancies other than MM, except if the participant has been free of the disease for ≥ 3 years. Patients with CIS treated with curative intent are not excluded if less than 3 years. Exceptions would include basal cell and squamous cell cancer of the skin treated with curative intent.\n  15. Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. The following are exceptions to this criterion: a. Intranasal, inhaled, topical or local corticosteroid injections (e.g., intra-articular injection). b. Systemic corticosteroids at doses that do not exceed 10 mg\u002Fday of prednisone or the equivalent. Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \\[CT\\] scan premedication).\n  16. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment:\n\n      A. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion); B. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); C. Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\] or pulmonary embolism); D. Prolonged QT syndrome (or QTcF \\>470 msec at screening); E. LVEF \\\u003C 40% as determined by a MUGA scan or echocardiography.\n  17. Subject has uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.\n  18. Subject who has had a live vaccine within 3 months of start of study therapy.\n  19. Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, active hepatitis A, or active hepatitis C:\n\n      A. Known positive HIV status. B. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\] either acute or chronic hepatitis). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBcAb\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBsAb\\]) 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: Subjects 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\n      EXCEPTION: Subjects with positive anti-HBcAb but negative HBsAg and negative anti-HBsAb profiles are eligible if HBV DNA PCR is negative.\n\n      C. Known to be seropositive for hepatitis C virus (HCV); anti-HCV antibody positive and HCV- ribonucleic acid (RNA) quantitation positive.\n  20. Ongoing Grade 3 or higher peripheral sensory or motor neuropathy, history of Guillan-Barre syndrome (GBS) or GBS variants, or history of any Grade \\>3 peripheral motor polyneuropathy.\n  21. Subject is an individual who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study.","19 Years",{"count":185,"type":20},40,[24],"This is an open-label, single arm, multicenter study to evaluate the efficacy of letermovir in the prevention of clinically significant CMV infection in adult, CMV-seropositive relapsed\u002Frefractory MM patients undergoing BsAbs therapy.",[27],"2025-11-25",{"date":191,"type":36},"2025-12-03",{"date":193,"type":36},"2025-09-11",{"date":195,"type":20},"2028-12-31",{"name":197,"class":71},"Seoul National University Hospital",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":183,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100565707","phase-1-mezigdomide-and-elranatamab-for-relapsed-andor-refractory-multiple-myeloma-100565707","NCT06645678","Mezigdomide and Elranatamab for Relapsed and\u002For Refractory Multiple Myeloma","Phase I\u002FII Study of Mezigdomide and Elranatamab for Relapsed\u002FRefractory Multiple Myeloma Patients","MELT-MM","Inclusion Criteria:\n\n* Subjects must satisfy the following criteria to be enrolled in the study:\n\n  * Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF).\n\n    ② Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n    * Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n\n      ④ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g\u002FdL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg\u002F24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n      \\*Patients with measurable disease and extramedullary disease will be allowed to participate if there is a measurable extramedullary lesion. These patients require PET-CT follow-up for response evaluation. Those with extramedullary disease (EMD) only will not be allowed to participate: i.e, Patients with plasmacytoma as the only measurable disease are not eligible. For the definition of EMD, refer to Section 8.1.3.\n\n      ⑤ Subject has received 2 or more prior lines of antimyeloma therapy. (Note: One line can contain several phases \\[e.g., induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and\u002For (with or without) maintenance therapy).\n\n      ⑥ Subject must have received at least one proteasome inhibitor and lenalidomide.\n\n      ⑦ Subject achieved minimal response or better to at least 1 prior antimyeloma therapy.\n      * Subject must have documented disease progression during or after their last antimyeloma regimen.\n\n        ⑨ Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.\n\n        ⑩ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n\nB. Either commit to true abstinence\\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of mezigdomide or 150 days after the last dose of elranatamab, whichever is longer.\n\nNote: A IOCBP (Individual of childbearing potential): an individual who: 1) has achieved menarche (first menstrual cycle) at some point; 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral salpingectomy (the surgical removal of the fallopian tubes) or oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (without an alternative medical cause eg, amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months).\n\n⑪ Male subjects must: A. Practice true abstinence\\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant individual or an individual of childbearing potential while participating in the study, during dose interruptions and for at least 28 days after the last dose of mezigdomide whichever is longer, even if he has undergone a successful vasectomy.\n\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. \\[Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n\n  * Male subjects must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 28 days following last dose of mezigdomide,\n\n    * Females must agree to refrain from donating eggs while on study treatment and for at least 28 days after last dose of mezigdomide.\n\n      * Subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of mezigdomide.\n\n        * Subjects must agree to refrain from receiving live vaccines while on study treatment, during dose interruptions and for at least 90 days following the last dose of the study treatment.\n\nExclusion Criteria: The presence of any of the following will exclude a subject from enrollment:\n\n* 1 Subject who has had prior treatment with mezigdomide. 2 Patients with gastrointestinal disease or surgery (eg, gastric bypass surgery) that may significantly alter the absorption of mezigdomide and\u002For other oral study intervention.\n\n  3 Subject who has had prior treatment with anti-BCMA agents (including CAR T-cell therapy, bispecifics and antibodies).\n\n  4 Subject who has had any investigational agents within 28 days or 5 half-lives (whichever is shorter) of initiating study treatment.\n\nA. Participation in another interventional clinical trial concurrent with this study is not permitted, except for those who have completed treatment with the prior investigational agent(s) and are currently in Long-term Follow up.\n\n5 Subject has received any of the following. A. Plasmapheresis within the last 28 days of initiating study treatment B. Major surgery (as defined by the Investigator) within 28 days of initiating study treatment.\n\nC. Radiation therapy, other than local palliative therapy, for myeloma associated bone lesions within 14 days of initiating study treatment.\n\nD. Use of any systemic antimyeloma drug therapy within 14 days of initiating study treatment.\n\nE. Use of potassium competitive acid blockers (eg. tegoprazan, vonoprazan) within 7 days of initiating study treatment.\n\n6 Subject has previously received allogeneic stem cell transplantation within a year during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study treatment. Patients who received allogeneic stem cell transplantation should not have evidence of active GVHD.\n\n7 Subject has plasma cell leukemia defined by IMWG definition for primary plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant light-chain amyloidosis.\n\n8 Subject with known central nervous system (CNS) involvement with myeloma. 9 Subject has any significant medical condition, including active or uncontrolled infection, presence of laboratory abnormality, or psychiatric illness that places the subject at an unacceptable risk for treatment-related complications, if he\u002Fshe were to participate in the study.\n\n10 Coronavirus disease 2019 (COVID-19) within 7 days for mild or asymptomatic infections or 14 days for moderate\u002Fsevere infections prior to initiating study intervention. A longer duration may be needed based on the investigator's clinical judgment.\n\ni) Acute symptoms must have resolved and there are no sequelae that would place the participant at a higher risk of receiving study intervention, based on investigator Assessment. No repeat\u002Ffollow-up COVID-19 testing is required\n\n11 Subject has any condition that confounds the ability to interpret data from the study.\n\n12 Subject has any of the following laboratory abnormalities: A. Absolute neutrophil count (ANC) \\\u003C 1,000\u002FµL. It is not permissible to administer GCSF to achieve minimum ANC levels within 7 days prior to screening complete blood count (CBC) (or within 14 days prior for pegfilgrastim).\\* B. Platelet count: \\\u003C 75,000\u002FµL for subjects in whom \\\u003C 50% of bone marrow nucleated cells are plasma cells; or a platelet count \\\u003C 50,000\u002FµL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells (transfusions are not permitted within 7 days prior to screening CBC).\\* C. Hemoglobin \\\u003C 8 g\u002FdL (\\\u003C 4.9 mmol\u002FL).\\*\n\n\\* Participants who do not meet criteria for hematologic function because of MM-related cytopenias (e.g. due to extensive marrow involvement by MM) may receive transfusions and be screened after 1 week of transfusion.\n\nD. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin or requiring dialysis. eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) formula.\n\nE. Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL) F. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN) G. Serum total bilirubin \\> 1.5 × ULN, or for participants with documented Gilbert's syndrome \\> 3.0 mg\u002FdL 13 Subject has peripheral neuropathy ≥ Grade 2 14 Subject with gastrointestinal disease or surgery (e.g., gastric bypass surgery) that may significantly alter the absorption of mezigdomide and\u002For other oral study treatment.\n\nA. Subject has a prior history of malignancies other than MM, except if the participant has been free of the disease for ≥ 3 years. Patients with CIS treated with curative intent are not excluded if less than 3 years. Exceptions would include basal cell and squamous cell cancer of the skin treated with curative intent.\n\n15 Subject has received immunosuppressive medication within the last 14 days of initiating study treatment. The following are exceptions to this criterion: a. Intranasal, inhaled, topical or local corticosteroid injections (e.g., intra-articular injection). b. Systemic corticosteroids at doses that do not exceed 10 mg\u002Fday of prednisone or the equivalent. c. Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \\[CT\\] scan premedication).\n\n16 Administration of strong CYP3A modulators; administration of proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study treatment.\n\n17 Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months prior to enrollment: A. Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion); B. Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); C. Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \\[unless associated with a central venous access complication\\] or pulmonary embolism); D. Prolonged QT syndrome (or QTcF \\> 470 msec at screening); E. LVEF \\\u003C40% as determined by a MUGA scan or echocardiography. 18 Subject has uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.\n\n19 Subject who has had a live vaccine within 3 months of start of study therapy.\n\n20 Subject is unable or unwilling to undergo protocol required thromboembolism or antiviral prophylaxis.\n\n21 Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, active hepatitis A, or active hepatitis C: A. Known positive HIV status. B. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\] either acute or chronic hepatitis). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBcAb\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBsAb\\]) 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\nEXCEPTION: Subjects 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\nEXCEPTION: Subjects with positive anti-HBcAb but negative HBsAg and negative anti-HBsAb profiles are eligible if HBV DNA PCR is negative.\n\nC. Known to be seropositive for hepatitis C virus (HCV); anti-HCV antibody positive and HCV- ribonucleic acid (RNA) quantitation positive.\n\n22 Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥ Grade 3 rash during prior IMiD therapy), or dexamethasone or the excipients contained in the formulations, or subject has any contraindications per local PI.\n\n23 Ongoing Grade 3 or higher peripheral sensory or motor neuropathy, history of Guillan-Barre syndrome (GBS) or GBS variants, or history of any Grade \\> 3 peripheral motor polyneuropathy.\n\n24 Subject is an individual who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study.",{"count":207,"type":20},75,[23,24],"The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory\u002Frelapsed multiple myeloma.",[27],[212,58,213],"R\u002FR MM","Mezigdomide",{"date":191,"type":36},{"date":216,"type":36},"2024-11-26",{"date":218,"type":20},"2027-10-01",{"name":220,"class":71},"YOUNGIL KOH",7]