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

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Full 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
Myeloma stage or condition:
Multiple Myeloma
Study phase:
Phase 3
Summary/Purpose:
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 all 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.
Detailed Description:
Not available
Treatments:
Drug : Elranatamab

subcutaneous

Drug : Daratumumab

Daratumumab / hyaluronidase, subcutaneous

Drug : Pomalidomide

oral

Drug : Dexamethasone

oral

Study Arms:
Experimental : Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
Experimental : Part 2 Randomized Arm A: Elranatamab
Experimental : Part 2 Randomized Arm B: Elranatamab + Daratumumab
Active Comparator : Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Study Type:
Interventional
Study Design:
Allocation: Randomized
Intervention Model: Factorial
Primary Purpose: Treatment
Masking: Single
Recruitment status:
(active not recruiting)
Eligibility criteria:
usion Criteria:
    * Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014). * Measurable disease based on IMWG criteria as defined by at least 1 of the following: * Serum M-protein ≥0.5 g/dL. * Urinary M-protein excretion ≥200 mg/24 hours. * Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65). * Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor. * ECOG performance status ≤2. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. * Not pregnant and willing to use contraception.
Exclusion Criteria:
    * Smoldering multiple myeloma. * Plasma cell leukemia. * Amyloidosis. * POEMS Syndrome. * Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease. * Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. * Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * Previous treatment with a BCMA-directed therapy. * Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study. * Live attenuated vaccine within 4 weeks of the first dose of study intervention. * Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Locations / Centres:

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta – ()

Cross Cancer Institute, Edmonton, Alberta – ()

QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia – ()

Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario – ()

Princess Margaret Cancer Centre, Toronto, Ontario – ()

Jewish General Hospital, Montreal, Quebec – ()

CIUSSS de l'Est-de-l'Île-de-Montréal, Montréal, Quebec – ()

Saskatoon Cancer Center, Saskatoon, Saskatchewan – ()

Contacts:
Not available
Publications:
???
First posted:
Not available
Actual start date:
2021-10-04
Last updated:
2025-02-05
Estimated enrollment:
761
Estimated completion date:
2027-05-31
Estimated primary completion date:
2025-08-01
Condition:
Multiple Myeloma
Gender:
All
Ages:
18 Years-
Accepts healthy volunteers:
Not available
Listed location countries:
Not available
NCT number:
NCT05020236
Other study ID numbers:
C1071005
Has Data monitoring committee:
Yes
U.S. FDA-regulated product:
Yes
IPD Sharing Statement :
???
Responsible party:
Sponsor
Study sponsor:
lead_sponsor
Pfizer
Industry
Collaborators:
???
Investigators:
Pfizer CT.gov Call Center Pfizer
Protocol Registration and Results System:
???
Verification date:
2025-02-01