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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,230
Specified dose on specified days
Specified dose on specified days
Progression-free survival (PFS)
Time frame: Up to 6 years
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
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Local Institution - 0202
Aurora, Colorado, United States
Local Institution - 0007
Jacksonville, Florida, United States
Local Institution - 0308
Tampa, Florida, United States
Local Institution - 0192
Tampa, Florida, United States
Local Institution - 0003
Weston, Florida, United States
Local Institution - 0019
Athens, Georgia, United States
Local Institution - 0018
Atlanta, Georgia, United States
Local Institution - 0021
Augusta, Georgia, United States
Local Institution - 0237
Chicago, Illinois, United States
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, United States
...and 259 more locations
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