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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


Description

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.

Trial 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 \</= 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 Info

Organization

Pfizer


Primary Outcome

Sub-Study A Phase 1: Dose Limiting Toxicity


Outcome Timeframe approximately 35 days

NCTID NCT05090566

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2021-10-27

Completion Date 2025-08-16

Enrollment Target 120

Interventions

DRUG Elranatamab + Nirogacestat

DRUG Elranatamab + lenalidomide + dexamethasone

Locations Recruiting

Banner Gateway Medical Center

United States, Arizona, Gilbert


Banner MD Anderson Cancer Center

United States, Arizona, Gilbert


University of Arkansas for Medical Sciences - Winthrop P. Rockefeller Cancer Institute

United States, Arkansas, Little Rock


Beverly Hills Cancer Center

United States, California, Beverly Hills


Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD

United States, California, Los Angeles


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