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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1
  • Drug: Elranatamab
    Specified dose on specified days
    Other names:
    • Elrexfio
    • PF-0686313
  • Drug: Mezigdomide
    Specified dose on specified days
    Other names:
    • BMS-986348
    • CC-92480
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron®
Experimental
Phase 2
  • Drug: Elranatamab
    Specified dose on specified days
    Other names:
    • Elrexfio
    • PF-0686313
  • Drug: Mezigdomide
    Specified dose on specified days
    Other names:
    • BMS-986348
    • CC-92480
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron®

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294-3300
Contact:
Luciano Costa, Site 0001
205-934-9695

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.