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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: BMS-986393 + Alnuctamab |
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Experimental Arm B: BMS-986393 + Mezigdomide |
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Experimental Arm C: BMS-986393 + Iberdomide |
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Experimental Arm D: BMS-986393 + Elranatamab |
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Experimental Arm E: BMS-986393 + Mezigdomide and Dexamethasone |
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Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294-3300
Birmingham, Alabama 35294-3300
Contact:
Susan Bal, Site 0008
205-934-1908
Susan Bal, Site 0008
205-934-1908
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona 85054
Phoenix, Arizona 85054
Contact:
Julia Wiedmeier-Nutor, Site 0002
855-776-0015
Julia Wiedmeier-Nutor, Site 0002
855-776-0015
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Contact:
Myo Htut, Site 0028
626-256-4673
Myo Htut, Site 0028
626-256-4673
Mayo Clinic in Florida
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
Sikander Ailawadhi, Site 0005
904-953-0853
Sikander Ailawadhi, Site 0005
904-953-0853
Northside Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Scott Solomon, Site 0006
404-255-1930
Scott Solomon, Site 0006
404-255-1930
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Jacalyn Rosenblatt, Site 0027
617-667-9920
Jacalyn Rosenblatt, Site 0027
617-667-9920
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Omar Nadeem, Site 0011
617-632-3000
Omar Nadeem, Site 0011
617-632-3000
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
Taxiarchis Kourelis, Site 0001
855-776-0015
Taxiarchis Kourelis, Site 0001
855-776-0015
University Of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Contact:
Christopher D'Angelo, Site 0010
402-559-8110
Christopher D'Angelo, Site 0010
402-559-8110
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601-2191
Hackensack, New Jersey 07601-2191
Contact:
David Siegel, Site 0004
551-996-8704
David Siegel, Site 0004
551-996-8704
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Contact:
Ehsan Malek, Site 0007
216-286-4441
Ehsan Malek, Site 0007
216-286-4441
Laura and Isaac Perlmutter Cancer Center
New York, New York 10016
New York, New York 10016
Contact:
Jingmei Hsu, Site 0022
646-501-4848
Jingmei Hsu, Site 0022
646-501-4848
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Sham Mailankody, Site 0012
646-608-3712
Sham Mailankody, Site 0012
646-608-3712
Tennessee Oncology
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, Site 0025
615-329-0570
Jesus Berdeja, Site 0025
615-329-0570
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Contact:
Krina Patel, Site 0003
713-792-6662
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.com855-907-3286
Clinical.Trials@bms.com