MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Official Title

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

Summary:

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in both parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Trial Description

Primary Outcome:

• Part 1 Safety Lead-In: Incidence of dose limiting toxicities
• Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria

• Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
• Overall survival
• Objective response rate per International Myeloma Working Group criteria
• Duration of response per International Myeloma Working Group criteria
• Time to response per International Myeloma Working Group criteria
• Complete response rate per International Myeloma Working Group criteria
• Duration of complete response per International Myeloma Working Group criteria
• Minimal residual disease negativity rate per International Myeloma Working Group criteria
• Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
• Progression free survival on next-line treatment per International Myeloma Working Group criteria
• Frequency of treatment-emergent adverse events
• Frequency of abnormal laboratory results
• Rate of Grade ≥2 cytokine release syndrome
• Elranatamab pharmacokinetics by pre- and post-dose concentrations
• Elranatamab immunogenicity by anti-drug antibodies against elranatamab
• Daratumumab pharmacokinetics by pre-dose concentrations
• Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
• Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

View this trial on ClinicalTrials.gov