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NCT06121843PHASE1Recruiting

A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Start Date

2/22/2024

Completion Date

8/1/2028

Summary

The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. * Adherence to contraception requirements. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2). * Other protocol-defined inclusion/exclusion criteria apply.

Interventions

DRUG

BMS-986393

DRUG

Alnuctamab

DRUG

Mezigdomide

DRUG

Iberdomide

DRUG

Elranatamab

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294-3300

United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona 85054

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Mayo Clinic in Florida

Jacksonville, Florida 32224

United States

Northside Hospital

Atlanta, Georgia 30342

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota 55905

United States

University Of Nebraska Medical Center

Omaha, Nebraska 68198

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601-2191

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

Local Institution - 0009

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Local Institution - 0023

Pittsburgh, Pennsylvania 15232

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada