Mezigdomide + Elranatamab for Multiple Myeloma

Recruiting at 19 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Celgene

Must not be taking: Mezigdomide, TCE, BCMA-targeting

Disqualifiers: Prior mezigdomide, TCE, BCMA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. Participants should meet specific health criteria not detailed here.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Adherence to contraception requirements

I am over 18 and have had 2-4 (Phase 1) or 1-3 (Phase 2) treatments for my relapsed multiple myeloma.

Exclusion Criteria

I have previously been treated with mezigdomide.

I have previously been treated with T cell engaging therapies.

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive mezigdomide in combination with elranatamab to determine the recommended dose and schedule

8-12 weeks

Phase 2 Treatment

Participants continue treatment to evaluate safety and preliminary efficacy

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for long-term outcomes, including survival and disease progression

Up to 5 years

Treatment Details

Interventions

• Dexamethasone
• Elranatamab
• Mezigdomide

Trial Overview The study tests the safety and initial effectiveness of combining two drugs, Mezigdomide and Elranatamab, along with Dexamethasone in a recommended dose for relapsed/refractory multiple myeloma.

Participant Groups

Group I: Phase 2 Experimental Treatment 3 Interventions

Group II: Phase 1 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania