Mezigdomide plus elranatamab for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1/2 study combines mezigdomide, a novel cereblon modulator, with elranatamab, a BCMA-directed T-cell engager, plus dexamethasone. Phase 1 uses dose-escalation to determine the recommended phase 2 dose and schedule, and phase 2 evaluates preliminary safety and efficacy. Eligible participants have measurable relapsed or refractory multiple myeloma and generally good performance status, with specific prior-treatment windows differing by phase. Key exclusions include prior mezigdomide, prior T-cell engaging therapies, and most prior BCMA-targeted treatments except autologous BCMA CAR-T given more than 6 months earlier.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Yale New Haven Hospital-Smilow Cancer Center
  New Haven, Connecticut, United States Recruiting
• Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Arthur J E Child Comprehensive Cancer Centre
  Calgary, Alberta, Canada Recruiting
• QEII Health Sciences Centre - Victoria General Site
  Halifax, Nova Scotia, Canada Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.