A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Summary
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).
Arms & interventions
- DrugIberdomide
Specified dose on specified days
- DrugLenalidomide
Specified dose on specified days
Outcome measures
Primary
Progression-free survival (PFS)
Time frame: Up to 6 years
Secondary
Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment
Time frame: Up to 6 years
Overall Survival
Time frame: Up to 12 years
Recommended iberdomide dose for Stage 2
Time frame: Up to 1 year
Area under the iberdomide plasma concentration-time curve from time zero to tau
Time frame: Up to 1 year
Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU)
Time frame: Up to 1 year
Maximum iberdomide concentration (Cmax)
Time frame: Up to 1 year
Time to maximum iberdomide plasma concentration (Tmax)
Time frame: Up to 1 year
Number of participants with adverse events (AEs)
Time frame: Up to 6 years
Progression-free survival on next line of treatment (PFS2)
Time frame: Up to 6 years
Achieving MRD negativity in participants with CR or better at any time after the date of randomization
Time frame: Up to 6 years
Conversion from MRD positive to MRD negative in participants with CR or better
Time frame: Up to 6 years
Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 1 year apart, without any examination showing MRD positive status in between assessments
Time frame: Up to 6 years
Time to progression (TTP)
Time frame: Up to 6 years
Time to next treatment (TTNT)
Time frame: Up to 6 years
Best response achieved prior to progressive disease (PD)
Time frame: Up to 6 years
Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30)
Time frame: Up to 6 years
Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20)
Time frame: Up to 6 years
Eligibility criteria
Study locations (44)
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012-5405
Mayo Clinic Florida
Jacksonville, Florida, 32224
Tampa General Hospital
Tampa, Florida, 33606
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612-9416
Cleveland Clinic
Weston, Florida, 33331-3609
University Cancer Blood Ctr
Athens, Georgia, 30607-1465
The Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322-1013
Augusta University - Georgia Cancer Center
Augusta, Georgia, 30912
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, 60637-1426
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, 66205-2003
Maryland Oncology Hematology, PA- Clinton
Clinton, Maryland, 20735-4230
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan, 48109-5000
Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit
Detroit, Michigan, 48202-2610
Cancer & Hematology Centers of Western Michigan (CHCWM)
Grand Rapids, Michigan, 49503
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905
Hattiesburg Clinic - Hematology & Oncology
Hattiesburg, Mississippi, 39401
Morristown Medical Center
Morristown, New Jersey, 07960
Local Institution - 0328
Brooklyn, New York, 11220-3313
Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola
Mineola, New York, 11501
NYU Langone Health
New York, New York, 10016-6402
Columbia University Medical Center - Herbert Irving Pavilion Location
New York, New York, 10032-3729
Clinical Research Alliance
Westbury, New York, 11590
Levine Cancer Institute
Charlotte, North Carolina, 28204
Novant Health Cancer Institute - Elizabeth
Charlotte, North Carolina, 28803-2493
Duke University Hospital
Durham, North Carolina, 27705-3976
Novant Health Cancer Institute Hematology - Forsyth
Winston-Salem, North Carolina, 27103
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd
Cincinnati, Ohio, 45236-2725
Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center)
Cleveland, Ohio, 44111
Cleveland Clinic
Cleveland, Ohio, 44195
Midwest Oncology Associates - Kansas City
Kansas, Ohio, 64132
Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center
Mayfield Heights, Ohio, 44124
Local Institution - 0013
Toledo, Ohio, 43623
Wooster Milltown Specialty and Surgery Center
Wooster, Ohio, 44691
Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center - Jeanes Campus
Philadelphia, Pennsylvania, 19111-2433
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
West Cancer Center
Germantown, Tennessee, 38138-1762
Tennessee Oncology
Nashville, Tennessee, 37203-1625
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
UT Southwestern-Harold C. Simmons Cancer Center
Dallas, Texas, 75390-0001
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000