A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

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

  • Multiple Myeloma

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 5412347, Colorado 5417618 80012-5405
Contact:
John Burke, Site 0202
303-925-0700

Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Sikander Ailawadhi, Site 0007
904-953-0853

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Contact:
Ivan Borrello, Site 0308
410-955-4967

H. Lee Moffitt Cancer Center & Research Institute
Tampa 4174757, Florida 4155751 33612-9416
Contact:
Melissa Alsina, Site 0192
813-745-7202

Cleveland Clinic
Weston 4178003, Florida 4155751 33331-3609
Contact:
Chakra Chaulagain, Site 0003
954-487-2124

University Cancer Blood Ctr
Athens 4180386, Georgia 4197000 30607-1465
Contact:
Charles Bodine, Site 0019

The Winship Cancer Institute of Emory University
Atlanta 4180439, Georgia 4197000 30322-1013
Contact:
Sagar Lonial, Site 0018
404-778-1900

Augusta University - Georgia Cancer Center
Augusta 4180531, Georgia 4197000 30912
Contact:
Amany Keruakous, Site 0021
706-721-2505

The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago 4887398, Illinois 4896861 60637-1426
Contact:
Benjamin Derman, Site 0237
847-275-8131

University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood 4281639, Kansas 4273857 66205-2003
Contact:
Al-Ola Abdallah, Site 0015
918-261-6196

Maryland Oncology Hematology, PA- Clinton
Clinton 4351871, Maryland 4361885 20735-4230
Contact:
Jose Mendoza, Site 0205
323-357-7100

UMass Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Muthalagu Ramanathan, Site 0279
774-442-3903

University of Michigan - Rogel Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109-5000
Contact:
Matthew Pianko, Site 0001
734-647-0118

Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
Detroit 4990729, Michigan 5001836 48202-2610
Contact:
Philip Kuriakose, Site 0257
313-916-1901

Cancer & Hematology Centers of Western Michigan (CHCWM)
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Andrew Sochacki, Site 0296
616-954-5554

Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Prashant Kapoor, Site 0303
507-284-0969

Hattiesburg Clinic - Hematology & Oncology
Hattiesburg 4429295, Mississippi 4436296 39401
Contact:
John Hrom, Site 0207
601-261-1700

Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Contact:
Mohamad Cherry, Site 0191
973-971-7906

Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
Mineola 5127134, New York 5128638 11501
Contact:
Gareth Morgan, Site 0288

NYU Langone Health
New York 5128581, New York 5128638 10016-6402
Contact:
Gareth Morgan, Site 0180

Columbia University Medical Center - Herbert Irving Pavilion Location
New York 5128581, New York 5128638 10032-3729
Contact:
Divaya Bhutani, Site 0020

Clinical Research Alliance
Westbury 5144040, New York 5128638 11590
Contact:
James D'Olimpio, Site 0274
646-872-8630

Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Leon Bernal-Mizrachi, Site 0331
678-787-7893

Novant Health Cancer Institute - Elizabeth
Charlotte 4460243, North Carolina 4482348 28803-2493
Contact:
Raymond Thertulien, Site 0005
646-708-2544

Duke University Hospital
Durham 4464368, North Carolina 4482348 27705-3976
Contact:
Cristina Gasparetto, Site 0281
919-668-8222

Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Raymond Thertulien, Site 0286
646-708-2544

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Leon Bernal-Mizrachi, Site 0322
678-787-7893

Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
Cincinnati 4508722, Ohio 5165418 45236-2725
Contact:
Kruti Patel, Site 0238
888-961-4156

Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Cleveland 5150529, Ohio 5165418 44111
Contact:
Sandra Mazzoni, Site 0299
216-445-2025

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Sandra Mazzoni, Site 0002
216-445-2025

Midwest Oncology Associates - Kansas City
Kansas 5159405, Ohio 5165418 64132
Contact:
Anis Toumeh, Site 0017

Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Mayfield Heights 5162188, Ohio 5165418 44124
Contact:
Sandra Mazzoni, Site 0301
216-445-2025

Wooster Milltown Specialty and Surgery Center
Wooster 5177358, Ohio 5165418 44691
Contact:
Sandra Mazzoni, Site 0300
216-445-2025

Willamette Valley Cancer Institute
Eugene 5725846, Oregon 5744337 97401
Contact:
Christopher Yasenchak, Site 0203
541-988-7932

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Adam Binder, Site 0012

Fox Chase Cancer Center - Jeanes Campus
Philadelphia 4560349, Pennsylvania 6254927 19111-2433
Contact:
Asya Varshavsky-Yanovsky, Site 0011

University of Pittsburgh - Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Kathleen Dorritie, Site 0253
412-647-0864

West Cancer Center
Germantown 4624601, Tennessee 4662168 38138-1762
Contact:
Jason Chandler, Site 0294
901-683-0055

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203-1625
Contact:
Jesus Berdeja, Site 0004
615-329-0570

Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas 4684888, Texas 4736286 75246
Contact:
Houston Holmes, Site 0193
214-584-3402

UT Southwestern-Harold C. Simmons Cancer Center
Dallas 4684888, Texas 4736286 75390-0001
Contact:
Larry Anderson, Site 0009
214-648-5906

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 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

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center