MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
*The trial information contained on this page was imported from ClinicalTrials.gov. Click here to view this trial on ClinicalTrials.gov.
- Full Title:
- A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
- Myeloma stage or condition:
- Multiple Myeloma
- Study phase:
- Phase 2
- Summary/Purpose:
- The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.
- Detailed Description:
- Not available
- Treatments:
- Drug : Elranatamab + Nirogacestat
BCMA-CD3 bispecific antibody + gamma secretase inhibitor
- Drug : Elranatamab + lenalidomide + dexamethasone
BCMA-CD3 bispecific antibody + immunomodulatory
- Study Arms:
- Experimental : Sub-Study A
BCMA-CD3 bispecific antibody + gamma secretase inhibitor - Experimental : Sub-Study B
BCMA-CD3 bispecific antibody + immunomodulatory drug
- Study Type:
- Interventional
- Study Design:
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
Inclusion Criteria:
- Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
- Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
- Measurable disease defined by at least one of the following: 1. Serum M-protein >/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion >/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC >/= 10 mg/dL (>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
- ECOG performance status 0 -1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade
- Active plasma cell leukemia
- Amyloidosis
- Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
- POEMS syndrome
- Any active uncontrolled bacterial, fungal, or viral infection
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
- Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
- Sub-Study A Only: Previous treatment with BCMA bispecific antibody
- Sub-Study B Only: Previous treatment with BCMA directed therapy
- Locations / Centres:
-
Tom Baker Cancer Center, Calgary, Alberta – Recruiting
The Ottawa Hospital - General Campus, Ottawa, Ontario – Recruiting
Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting
- Contacts:
- Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
- Publications:
- ???
- First posted:
- 2021-10-25
- Actual start date:
- October 27, 2021
- Last updated:
- 2024-04-11
- Estimated enrollment:
- 120
- Estimated completion date:
- 2027-07-02
- Estimated primary completion date:
- 2025-08-16
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Canada
- United States
- NCT number:
- NCT05090566
- Other study ID numbers:
- C1071004
- Has Data monitoring committee:
- No
- 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:
- 2024-04-01