Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Myeloma
Enrollment Eligibility
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 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