NCT05020236: Phase 3-MagnetisMM-5: Elranatamab (PF-06863135) Vs & Elranatamab/Dara VS Dara/Pom/Dex
Updated: Feb 10
MagnetisMM-5
Relapsed Refractory Multiple Myeloma
NCT05020236: Phase 3 - MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)
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.
Sponsor
ClinicalTrials.gov Identifier: NCT04649359
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 2 PRIOR LINES OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
First Posted : August 25, 2021
Click here for details on Clinicaltrials.gov
Elranatamab (Code C146860)
Anti-CD3/Anti-BCMA Bispecific Antibody PF-06863135
B-cell Maturation Antigen-CD3 Bispecific Antibody PF-06863135
BCMA x CD3 Bispecific Antibody PF-06863135
BCMA-CD3 Bispecific Ab PF-06863135
Elranatamab
ELRANATAMAB
PF 06863135
PF-06863135
PF06863135
RN 613
RN-613
RN613
Drug: Elranatamab
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone
Locations
Canada, Nova Scotia
Canada, Ontario
Europe
Spain
Greece
Finland
Poland
Sweden
Turkey
Asia
India
Japan
Korea, Republic of
Taiwan
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