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Purpose

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Condition

Eligibility

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

Inclusion Criteria

  • Confirmed diagnosis of symptomatic multiple myeloma (MM). - Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2. - Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, daratumumab + bortezomib/thalidomide/dexamethasone [D-VTd] and daratumumab + bortezomib/ lenalidomide/dexamethasone [D-VRd]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone [D-VCd], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted. - Participants within 12 months (single transplant) or 15 months (tandem transplant) from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria.

Exclusion Criteria

  • Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy. - Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma. - Known central nervous system/meningeal involvement of MM. - Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1: Iberdomide Dose 1
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Experimental
Arm A2: Iberdomide Dose 2
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Experimental
Arm A3: Iberdomide Dose 3
  • Drug: Iberdomide
    Specified dose on specified days
    Other names:
    • CC-220
    • BMS-986382
Active Comparator
Arm B: Lenalidomide
  • Drug: Lenalidomide
    Specified dose on specified days
    Other names:
    • Revlimid®

Recruiting Locations

Rocky Mountain Cancer Centers
Aurora, Colorado 80012-5405
Contact:
John Burke, Site 0202
303-925-0700

Mayo Clinic Florida
Jacksonville, Florida 32224
Contact:
Sikander Ailawadhi, Site 0007
904-953-2000

Tampa General Hospital
Tampa, Florida 33606
Contact:
Ivan Borrello, Site 0308
410-955-4967

H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612-9416
Contact:
Melissa Alsina, Site 0192
813-745-7202

Cleveland Clinic
Weston, Florida 33331-3609
Contact:
Chakra Chaulagain, Site 0003
954-487-2124

University Cancer Blood Ctr
Athens, Georgia 30607-1465
Contact:
Charles Bodine, Site 0019

The Winship Cancer Institute of Emory University
Atlanta, Georgia 30322-1013
Contact:
Sagar Lonial, Site 0018
404-778-1900

Augusta University - Georgia Cancer Center
Augusta, Georgia 30912
Contact:
Amany Keruakous, Site 0021
706-721-2505

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois 60637-1426
Contact:
Benjamin Derman, Site 0237
847-275-8131

University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas 66205-2003
Contact:
Al-Ola Abdallah, Site 0015
918-261-6196

Maryland Oncology Hematology, PA- Clinton
Clinton, Maryland 20735-4230
Contact:
Jose Mendoza, Site 0205
323-357-7100

UMass Memorial Medical Center
Worcester, Massachusetts 01655
Contact:
Muthalagu Ramanathan, Site 0279
774-442-3903

University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan 48109-5000
Contact:
Matthew Pianko, Site 0001
734-647-0118

Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
Detroit, Michigan 48202-2610
Contact:
Philip Kuriakose, Site 0257
313-916-1901

Cancer & Hematology Centers of Western Michigan (CHCWM)
Grand Rapids, Michigan 49503
Contact:
Andrew Sochacki, Site 0296
616-954-5554

Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota 55905
Contact:
Prashant Kapoor, Site 0303
507-284-0969

Hattiesburg Clinic - Hematology & Oncology
Hattiesburg, Mississippi 39401
Contact:
John Hrom, Site 0207
601-261-1700

Morristown Medical Center
Morristown, New Jersey 07960
Contact:
Mohamad Cherry, Site 0191
973-971-7906

Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York 11501
Contact:
Gareth Morgan, Site 0288

NYU Langone Health
New York, New York 10016-6402
Contact:
Gareth Morgan, Site 0180

Columbia University Medical Center - Herbert Irving Pavilion Location
New York, New York 10032-3729
Contact:
Divaya Bhutani, Site 0020

Clinical Research Alliance
Westbury, New York 11590
Contact:
James D'Olimpio, Site 0274
646-872-8630

Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina 28803-2493
Contact:
Raymond Thertulien, Site 0005
646-708-2544

Duke University Hospital
Durham, North Carolina 27705-3976
Contact:
Cristina Gasparetto, Site 0281
919-668-1017

Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem, North Carolina 27103
Contact:
Raymond Thertulien, Site 0286
646-708-2544

Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
Cincinnati, Ohio 45236-2725
Contact:
Kruti Patel, Site 0238
888-961-4156

Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Cleveland, Ohio 44111
Contact:
Sandra Mazzoni, Site 0299
216-445-2025

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Sandra Mazzoni, Site 0002
216-445-2025

Midwest Oncology Associates - Kansas City
Kansas, Ohio 64132
Contact:
Anis Toumeh, Site 0017

Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Sandra Mazzoni, Site 0301
216-445-2025

Wooster Milltown Specialty and Surgery Center
Wooster, Ohio 44691
Contact:
Sandra Mazzoni, Site 0300
216-445-2025

Willamette Valley Cancer Institute
Eugene, Oregon 97401
Contact:
Christopher Yasenchak, Site 0203
541-988-7932

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Adam Binder, Site 0012

Fox Chase Cancer Center - Jeanes Campus
Philadelphia, Pennsylvania 19111-2433
Contact:
Asya Varshavsky-Yanovsky, Site 0011

University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Contact:
Kathleen Dorritie, Site 0253
412-647-0864

West Cancer Center
Germantown, Tennessee 38138-1762
Contact:
Jason Chandler, Site 0294
901-683-0055

Tennessee Oncology
Nashville, Tennessee 37203-1625
Contact:
Jesus Berdeja, Site 0004
615-329-0570

Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
Contact:
Houston Holmes, Site 0193
214-584-3402

UT Southwestern-Harold C. Simmons Cancer Center
Dallas, Texas 75390-0001
Contact:
Larry Anderson, Site 0009
214-648-5906

University of Texas MD Anderson Cancer Center
Houston, Texas 77030-4000
Contact:
Oren Pasvolsky, Site 0006
832-728-1403

More Details

NCT ID
NCT05827016
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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