Mezigdomide plus elranatamab for relapsed or refractory multiple myeloma
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
This test tries adding mezigdomide to elranatamab (with dexamethasone) to see if it is safe and can help adults with relapsed or refractory multiple myeloma who have had 1–4 prior treatments (eligibility differs by phase).
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celgene Industry-sponsored |
| Drugs / interventions | CART, elranatamab |
| Locations | 22 sites (Birmingham, Alabama and 21 other locations) |
| Trial ID | NCT06988488 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with measurable relapsed or refractory multiple myeloma, ECOG 0–1, who meet the trial's prior-treatment windows (phase 1: 2–4 prior lines; phase 2: 1–3 prior lines) and who have not previously received mezigdomide, T-cell engagers, or most BCMA-targeted therapies are the intended candidates.
Not a fit: Patients who previously received mezigdomide, prior T-cell engaging therapies, or recent BCMA-targeted treatments (with the limited exception of autologous BCMA CAR-T given >6 months earlier), or those with poor performance status or significant comorbidities, are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the combination could offer a new treatment option that produces deeper or longer responses for people with relapsed or refractory multiple myeloma.
How similar studies have performed: BCMA-targeting T-cell engagers such as elranatamab have shown single-agent activity in relapsed myeloma and IMiD/CELMoD agents have supporting rationale, but the specific combination with mezigdomide is relatively new with limited published data so far.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 21 other locations
- 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)
- Local Institution - 0026 — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Local Institution - 0027 — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- Local Institution - 0030 — Suzhou, Jiangsu, China (Not_yet_recruiting)
- Local Institution - 0031 — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
- Universitaetsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- Evangelismos General Hospital of Athens — Athens, Attikí, Greece (Recruiting)
- Alexandra General Hospital of Athens — Athens, Attikí, Greece (Recruiting)
- St. Olavs Hospital — Trondheim, Sør-Trøndelag, Norway (Recruiting)
- Sykehusapoteket Ull — Oslo, Norway (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca — Salamanca, Spain (Recruiting)
- University College London Hospital — London, England, United Kingdom (Recruiting)
- Royal Marsden Hospital (Sutton) — London, Sutton, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.