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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06988488Sponsor: CelgeneLast updated: 2026-05-28

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).

Arms & interventions

  • DrugElranatamab

    Specified dose on specified days

  • DrugMezigdomide

    Specified dose on specified days

  • DrugDexamethasone

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with Adverse Events (AEs)

    Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

  • Number of participants with Serious AEs

    Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

  • Number of participants with AEs meeting protocol-defined DLT criteria

    Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

  • Number of participants with AEs leading to discontinuation

    Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

  • Number of deaths

    Time frame: From first participant first visit until 28 days after the last mezigdomide dose or 90 days after last elranatamab dose, whichever is longer

  • Recommended Phase 2 Dose (RP2D)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

Secondary

  • International Myeloma Working Group (IMWG) Uniform Response Criteria: Overall Response Rate (ORR)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Complete Response Rate (CRR)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Very Good Partial Response Rate (VGPRR)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Time to Response (TTR)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Duration of Response (DOR)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Progression-free Survival (PFS)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • IMWG Uniform Response Criteria: Overall Survival (OS)

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

  • Number of participants who achieve minimal residual disease (MRD) negativity

    Time frame: From first participant enrollment until the last participant is no longer evaluable for response or has progressed or the last survival follow-up (At approximately 5 years)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Recruiting
Luciano Costa, Site 0001 · Contact
205-934-9695

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, 06510

Recruiting
Noffar Bar, Site 0029 · Contact
000-000-0000

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
David Siegel, Site 0028 · Contact
551-996-8704

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Jing Christine Ye, Site 0005 · Contact
734-232-0744
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 | Cancerify