Status:
RECRUITING
A 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
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 (RRM...
Eligibility Criteria
Inclusion
- 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
- 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 participants who have received autologous BCMA-targeted CART-cell therapy\> 6 months from the start of study therapy
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 3 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06988488
Start Date
October 7 2025
End Date
June 3 2027
Last Update
January 6 2026
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, United States, 06510
3
Local Institution - 0028
Hackensack, New Jersey, United States, 07601
4
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030