MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
- Interventional
- Recruiting
- NCT05090566
Contact Information
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
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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
- 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