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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
View on ClinicalTrials.gov →
NCT06988488
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 siteUniversity of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Luciano Costa, Site 0001205-934-9695
Connecticut
1 siteYale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510
Noffar Bar, Site 0029000-000-0000
New Jersey
1 siteHackensack University Medical Center
Hackensack, New Jersey, 07601
David Siegel, Site 0028551-996-8704
Texas
1 siteUniversity of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Jing Christine Ye, Site 0005734-232-0744
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Actively Recruiting
PhasePhase 1/2
SponsorCelgene
Started2025-10-07
Est. completion2027-05-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →
NCT06988488