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 trial information contained on this page was imported from ClinicalTrials.gov. Click here to view this trial on ClinicalTrials.gov.
- 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 Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
Inclusion 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.
- 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:
-
Tom Baker Cancer Center, Calgary, Alberta – Active, not recruiting
Cross Cancer Institute, Edmonton, Alberta – Active, not recruiting
QEII Health Sciences Centre - Victoria General Site, Halifax, Nova Scotia – Active, not recruiting
Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia – Active, not recruiting
Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Ontario – Active, not recruiting
Princess Margaret Cancer Centre, Toronto, Ontario – Active, not recruiting
Jewish General Hospital, Montreal, Quebec – Active, not recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal, Montréal, Quebec – Active, not recruiting
Saskatoon Cancer Center, Saskatoon, Saskatchewan – Active, not recruiting
- Contacts:
- Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
- Publications:
- ???
- First posted:
- 2021-08-25
- Actual start date:
- October 4, 2021
- Last updated:
- 2024-03-08
- Estimated enrollment:
- 762
- Estimated completion date:
- 2026-09-28
- Estimated primary completion date:
- 2024-12-27
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Finland
- France
- Germany
- Greece
- Italy
- Japan
- Korea, Republic of
- Mexico
- Netherlands
- New Zealand
- Norway
- Poland
- Spain
- Sweden
- Taiwan
- Turkey
- United Kingdom
- United States
- 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:
- 2024-03-01