Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

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"

DRUG

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"

DRUG

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.

DRUG

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.

DRUG

Dara-VRd induction

Patients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone

Trial Locations (10)

10032

RECRUITING

Columbia University, New York

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

37232

RECRUITING

Vanderbilt University, Nashville

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

53792

RECRUITING

University of Wisconsin - Carbone, Madison

75390

RECRUITING

University of Texas Southwestern, Dallas

80218

RECRUITING

Colorado Blood Cancer Institute, Denver

84112

NOT_YET_RECRUITING

University of Utah, Salt Lake City

97239

RECRUITING

Oregon Health and Science University, Portland

98109

RECRUITING

University of Washington, Seattle

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

Sarah Cannon

INDUSTRY

lead

University of Alabama at Birmingham

OTHER