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MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

RecruitingPhase 3Ages 18 Years - anyAllPfizer
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide. * Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria. * Measurable disease defined as at least 1 of the following: (a) Serum M-protein โ‰ฅ0.5 g/dL; (b) Urinary M-protein excretion โ‰ฅ200 mg/24 hours; (c) Serum involved immunoglobulin FLC โ‰ฅ10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65). * Have clinical laboratory values within the specified range. * ECOG (Eastern Cooperative Oncology Group) performance status โ‰ค2. * Not pregnant or breastfeeding and willing to use contraception. Exclusion Criteria: * Smoldering multiple myeloma. * Plasma cell leukemia. * Amyloidosis. * Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome. * Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease. * Any active, uncontrolled bacterial, fungal, or viral infection. * Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ) * Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy. * Unable to receive investigator's choice therapy. * Live attenuated vaccine within 4 weeks of the first dose of study intervention. * Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
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What it tests

  • Elranatamab
  • Elotuzumab
  • Pomalidomide
  • Dexamethasone
  • Bortezomib
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Where

270 sites
Infirmary Cancer Care
Mobile, United States
Western Regional Medical Center, Inc. dba. City of Hope Phoenix
Goodyear, United States
Beverly Hills Cancer Center
Beverly Hills, United States
Clovis Community Medical Center
Clovis, United States
Community Cancer Institute
Clovis, United States
Clinical Research Advisors (Encino Satellite Location)
Encino, United States
University of California San Francisco
Fresno, United States
Community Regional Medical Center
Fresno, United States

โ€ฆand 262 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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