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

Phase 2RecruitingNCT06988488

Celgene62 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

ElranatamabDRUG

Specified dose on specified days

MezigdomideDRUG

Specified dose on specified days

DexamethasoneDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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 Outcomes

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)

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Yale New Haven Hospital-Smilow Cancer Center

New Haven, Connecticut, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

RECRUITING

Local Institution - 0026

Vancouver, British Columbia, Canada

NOT_YET_RECRUITING

Local Institution - 0027

Halifax, Nova Scotia, Canada

NOT_YET_RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Local Institution - 0030

Suzhou, Jiangsu, China

NOT_YET_RECRUITING

Local Institution - 0031

Shanghai, Shanghai Municipality, China

NOT_YET_RECRUITING

...and 12 more locations

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

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

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)