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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

RECRUITINGPhase 1/2Sponsored by Celgene
Actively Recruiting
PhasePhase 1/2
SponsorCelgene
Started2025-10-07
Est. completion2027-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites

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: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerMultiple Myeloma

Locations4 sites

Alabama

1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Luciano Costa, Site 0001205-934-9695

Connecticut

1 site
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510
Noffar Bar, Site 0029000-000-0000

New Jersey

1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
David Siegel, Site 0028551-996-8704

Texas

1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jing Christine Ye, Site 0005734-232-0744

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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