A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma
Celgene
Summary
The purpose of this study is to evaluate the preliminary safety and determine the RP2D of mezigdomide in combination with elranatamab in participants with relapsed and refractory multiple myeloma (RRMM).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 with history of relapsed and refractory multiple myeloma (RRMM) treated with 2 to 4 prior lines of anti-myeloma therapy (Phase 1) or 1 to 3 prior lines of anti-myeloma therapy (Phase 2). * Measurable MM by local laboratory. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. * Adherence to contraception requirements. Exclusion Criteria: * Prior treatment with mezigdomide. * Prior treatment with T cell engaging or T cell engager (TCE). * Prior treatment with B cell-maturation antigen (BCMA)-targeting therapy, with the exception of partic…
Interventions
- DrugElranatamab
Specified dose on specified days
- DrugMezigdomide
Specified dose on specified days
- DrugDexamethasone
Specified dose on specified days
Locations (22)
- University of Alabama at BirminghamBirmingham, Alabama
- Yale New Haven Hospital-Smilow Cancer CenterNew Haven, Connecticut
- Hackensack University Medical CenterHackensack, New Jersey
- University of Texas MD Anderson Cancer CenterHouston, Texas
- Arthur J E Child Comprehensive Cancer CentreCalgary, Alberta
- Local Institution - 0026Vancouver, British Columbia