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
Sponsor: Celgene
Sponsor score: 60
ClinicalTrials ID:NCT06988488
This clinical trial assesses the safety and determines the recommended Phase 2 dose of mezigdomide with elranatamab in RRMM patients. Eligible participants are adults with 1-4 prior anti-myeloma therapies and an ECOG PS of 0-1. The study involves administering specified doses of elranatamab, mezigdomide, and dexamethasone on designated days, with adherence to contraception requirements.
Patient Parameters
| Parameter | Options |
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Program Overview
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 Criteria
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 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294-3300 | Birmingham | Alabama |
| Yale New Haven Hospital-Smilow Cancer Center | 06510 | New Haven | Connecticut |
| Local Institution - 0028 | 07601 | Hackensack | New Jersey |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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