MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
Multiple MyelomaThe 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.
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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 \</= 1
Exclusion Criteria:
* 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
Study Location
Arthur J.E. Child Comprehensive Cancer Centre
Arthur J.E. Child Comprehensive Cancer CentreCalgary, Alberta
Canada
Contact Study Team
The Ottawa Hospital - General Campus
The Ottawa Hospital - General CampusOttawa, Ontario
Canada
Contact Study Team
Princess Margaret Cancer Centre
Princess Margaret Cancer CentreToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Pfizer
- Participants Required
- More Information
- Study ID:
NCT05090566