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)

• Elranatamab (Drug): Elranatamab will be administered subcutaneously
• Elotuzumab (Drug): Elotuzumab will be administered intravenously
• Pomalidomide (Drug): Pomalidomide will be administered orally
• Dexamethasone (Drug): Dexamethasone will be administered orally
• Bortezomib (Drug): Bortezomib will be administered subcutaneously or intravenously
• Carfilzomib (Drug): Carfilzomib will be administered intravenously

Primary outcomes

• Progression free survival per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first

Secondary outcomes

• Overall survival [Up to approximately 5 years]: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
• Progression free survival on next-line treatment per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first
• Objective response rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy
• Duration of response per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
• Very good partial response or better response rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
• Complete response rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
• Duration of complete response per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
• Time to response per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of confirmed objective response
• Minimal residual disease negativity rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
• Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
• Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria [Up to approximately 5 years]: From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first
• Frequency of treatment-emergent adverse events [From date of first dose of study intervention up to 90 days after last study intervention administration]
• Frequency of abnormal laboratory results [From date of first dose of study intervention up to 90 days after last study intervention administration]
• Free elranatamab serum trough concentration [Ctrough] [From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab]
• Elranatamab immunogenicity by anti-drug antibodies against elranatamab [From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab]
• Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [From date of informed consent up to approximately 35 days after last administration of study intervention]: Change from baseline scores
• Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [From date of informed consent up to approximately 35 days after last administration of study intervention]: Change from baseline scores

Sex: All, ages: 18 Years to any

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 ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 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 ≤2.
* 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.

170 more sites not listed.

• Pfizer CT.gov Call Center, Study director, Pfizer

NIH grants: 2023