• Recruiting

NCT05020236: Phase 3-MagnetisMM-5: Elranatamab (PF-06863135) Vs & Elranatamab/Dara VS Dara/Pom/Dex

Updated: Sep 16

MagnetisMM-5

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

Pfizer

 

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


Multiple Myeloma Clinical Trial | Pfizer (pfizerclinicaltrials.com)


You don’t have to take on multiple myeloma alone | Pfizer Clinical Trials

 

Elranatamab


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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