300
Participants
Start Date
December 13, 2023
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
Dara-VRd intensification, Dara-R maintenance
"Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort~• MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance"
AHCT intensification, Dara-R maintenance
"Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort~• MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance"
AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
AHCT intensification, Dara-R consolidation, Dara-R maintenance
Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
Dara-VRd induction
Patients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone
RECRUITING
Columbia University, New York
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
Vanderbilt University, Nashville
RECRUITING
Medical College of Wisconsin, Milwaukee
RECRUITING
University of Wisconsin - Carbone, Madison
RECRUITING
University of Texas Southwestern, Dallas
RECRUITING
Colorado Blood Cancer Institute, Denver
NOT_YET_RECRUITING
University of Utah, Salt Lake City
RECRUITING
Oregon Health and Science University, Portland
RECRUITING
University of Washington, Seattle
Janssen Scientific Affairs, LLC
INDUSTRY
Sarah Cannon
INDUSTRY
University of Alabama at Birmingham
OTHER