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NCT Number: NCT06988488

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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elranatamab

Drug

Specified dose on specified days

Other names: Elrexfio, PF-0686313

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Dexamethasone

Drug

Specified dose on specified days

Other names: Decadron®

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

    Defined as less than 1 in 10^5 nucleated cells in BMA for participants who achieve CR or better at any time after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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