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Purpose

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

Condition

Eligibility

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

Inclusion Criteria

  • Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:. i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or. ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,. iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels > 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio. - Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, [with or without] hematopoietic stem cell transplant, (with or without) consolidation, and/or [with or without] maintenance therapy). - Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received < 2 cycles are still eligible). - Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy. - Participant must have documented disease progression during or after their last antimyeloma regimen.

Exclusion Criteria

  • Participant who has had prior treatment with mezigdomide or carfilzomib. - Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a two-stage inferentially seamless design.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
This is an open-label study; however, any review of aggregate study data by the Sponsor will be performed in a blinded manner.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MeziKd (Mezigdomide + Carfilzomib + Dexamethasone)
  • Drug: Mezigdomide
    Specified dose on specified days
    Other names:
    • BMS-986348
    • CC-92480
  • Drug: Carfilzomib
    Specified dose on specified days
    Other names:
    • Kyprolis
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron
    • Dex
Active Comparator
Kd (Carfilzomib + Dexamethasone)
  • Drug: Carfilzomib
    Specified dose on specified days
    Other names:
    • Kyprolis
  • Drug: Dexamethasone
    Specified dose on specified days
    Other names:
    • Decadron
    • Dex

Recruiting Locations

USA Mitchell Cancer Institute
Mobile, Alabama 36604
Contact:
Omar Alkharabsheh, Site 0046
251-665-8000

TOI Clinical Research
Cerritos, California 90703
Contact:
Amitabha Mazumder, Site 0005
562-693-4477

Kaiser Permanente - Irvine
Irvine, California 92618
Contact:
Ashraf Aziz, Site 0190
800-398-3996

Los Angeles Hematology Oncology Medical Group
Los Angeles, California 90017
Contact:
Lasika Seneviratne, Site 0187
626-627-6666

Sutter Santa Rosa
Santa Rosa, California 95403
Contact:
Zeyad Kanaan, Site 0344
707-521-7750

Stockton Hematology Oncology Group
Stockton, California 95204
Contact:
Neelesh Bangalore, Site 0339
209-466-2626

Florida Cancer Specialists - South
Fort Myers, Florida 33901
Contact:
Syed Zafar, Site 0341
239-274-9930

Florida Cancer Specialists - North
Saint Petersburg, Florida 33705
Contact:
Gustavo Fonseca, Site 0342
000-000-0000

Florida Cancer Specialists - East
West Palm Beach, Florida 33401
Contact:
Shachar Peles, Site 0340
561-366-4100

Emory University School of Medicine- Grady Campus
Atlanta, Georgia 30303
Contact:
Nisha Joseph, Site 0348
502-608-5503

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Contact:
Nisha Joseph, Site 0291
502-608-5503

Anne Arundel Medical Center
Annapolis, Maryland 21401
Contact:
Imad Tabbara, Site 0289
703-217-1760

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Monique Hartley-Brown, Site 0204
857-299-5736

Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota 55404
Contact:
Sandeep Jain, Site 0346
952-892-7190

Regional Cancer Care Associates
Little Silver, New Jersey 07739
Contact:
iuliana Shapira, Site 0222
732-530-8666

Montefiore Medical Center
Bronx, New York 10467
Contact:
Ridhi Gupta, Site 0199
718-920-4826

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
James Ignatz-Hoover, Site 0322
440-897-3232

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Yvonne Efebera, Site 0172
216-965-8569

Lifespan Cancer Institute
Providence, Rhode Island 02903
Contact:
Rabin Niroula, Site 0321
401-444-3000

Gibbs Cancer Center & Research Institute
Greer, South Carolina 29650
Contact:
Tondre Buck, Site 0338
864-560-7050

Tennessee Oncology Chattanooga
Chattanooga, Tennessee 37404
Contact:
Jesus Berdeja, Site 0349
615-329-0570

Tennessee Oncology
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, Site 0323
615-329-0570

John Peter Smith Hospital
Fort Worth, Texas 76104
Contact:
Kalyani Narra, Site 0337
817-702-8049

Kelsey-Seybold Clinic
Houston, Texas 77025
Contact:
Tri Vu, Site 0328
713-442-1223

Houston Methodist Hospital
Houston, Texas 77030
Contact:
Carrie Yuen, Site 0044
832-571-7244

Virginia Oncology Associates
Norfolk, Virginia 23502
Contact:
David Kobulnicky, Site 0345

Blue Ridge Cancer Care
Roanoke, Virginia 24014
Contact:
Amanda Gillespie-Twardy, Site 0343
540-982-0237

Northwest Medical Specialties PLLC
Tacoma, Washington 98405
Contact:
Francis Senecal, Site 0006
253-428-8700

Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
Contact:
Tristan Bice, Site 0347
360-944-9889

WVU Cancer Institute
Morgantown, West Virginia 26506
Contact:
Salah ud din Safi, Site 0243
304-598-6984

Marshfield Medical Center - Marshfield
Marshfield, Wisconsin 54449
Contact:
Isaac Yeboah, Site 0336
715-387-5416

Pan American Center for Oncology Trials - Ciudadela
San Juan, Puerto Rico 00909
Contact:
Maria Garcia-Pallas, Site 0316
7874073333

More Details

NCT ID
NCT05552976
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

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

Notice

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