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

Purpose

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).

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: BMS-986393 + Alnuctamab
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266
    • Arlocabtagene autoleucel
    • arlo-cel
  • Drug: Alnuctamab
    Specified dose on specified days
    Other names:
    • BMS-986349
    • CC-93269
    • EM901
Experimental
Arm B: BMS-986393 + Mezigdomide
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266
    • Arlocabtagene autoleucel
    • arlo-cel
  • Drug: Mezigdomide
    Specified dose on specified days
    Other names:
    • BMS-986348
    • CC-92480
Experimental
Arm C: BMS-986393 + Iberdomide
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266
    • Arlocabtagene autoleucel
    • arlo-cel
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • BMS-986382
    • CC-220
Experimental
Arm D: BMS-986393 + Elranatamab
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266
    • Arlocabtagene autoleucel
    • arlo-cel
  • Drug: Elranatamab
    Specified dose on specified days
    Other names:
    • Elrexfio
Experimental
Arm E: BMS-986393 + Mezigdomide and Dexamethasone
  • Drug: BMS-986393
    Specified dose on specified days
    Other names:
    • CC-95266
    • Arlocabtagene autoleucel
    • arlo-cel
  • 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, Alabama 35294-3300
Contact:
Susan Bal, Site 0008
205-934-1908

Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona 85054
Contact:
Julia Wiedmeier-Nutor, Site 0002
855-776-0015

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Myo Htut, Site 0028
626-256-4673

Mayo Clinic in Florida
Jacksonville, Florida 32224
Contact:
Sikander Ailawadhi, Site 0005
904-953-0853

Northside Hospital
Atlanta, Georgia 30342
Contact:
Scott Solomon, Site 0006
404-255-1930

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Jacalyn Rosenblatt, Site 0027
617-667-9920

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Omar Nadeem, Site 0011
617-632-3000

Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Contact:
Taxiarchis Kourelis, Site 0001
855-776-0015

University Of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Christopher D'Angelo, Site 0010
402-559-8110

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601-2191
Contact:
David Siegel, Site 0004
551-996-8704

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Ehsan Malek, Site 0007
216-286-4441

Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
Contact:
Jingmei Hsu, Site 0022
646-501-4848

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Sham Mailankody, Site 0012
646-608-3712

Tennessee Oncology
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, Site 0025
615-329-0570

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Krina Patel, Site 0003
713-792-6662

More Details

Status
Recruiting
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Study Contact

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