310
Participants
Start Date
February 11, 2020
Primary Completion Date
February 1, 2027
Study Completion Date
February 1, 2027
Bortezomib
1.3 mg/m2 administered Subcutaneous (SC) or intravenous (IV) on days 1, 4, 8 and 11 of a 21 day treatment cycle for participants randomized to Arm A.
Dexamethasone
"20 mg or 40 mg per dose administered by mouth (PO) or IV.~Participants randomized in Arm A:~20 mg/dose on days 1, 4, 8 and 11 on a 21 day treatment cycle;~Participants randomized in Arm B:~Cycles 1 through 8 - 40mg/dose on days 1, 8 and 15 on a 28-day cycle~Participants randomized in Arm C:~Cycle 1-2 - 40 mg/dose on days 1, 8, 15 and 22 on a 28-day cycle; Cycles 3-8 - 40mg/dose on Days 1, 8, 15 on a 28-day cycle;"
Lenalidomide
"10 or 25 mg/day capsules administered PO.~Participants randomized in Arm A:~25 mg/day capsules on Days 1 through 14 of a 21 day cycle.;~Participants randomized in Arm B:~Cycles 1 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;~Participants randomized in Arm C:~Cycles 1 - 25 mg/day capsules on Days 2 through 21 of a 28 day cycle; Cycles 2 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;~Maintenance Therapy:~10 mg capsules on Days 1 through 21 on a 28 days cycle."
Acetaminophen
"650 mg administered PO.~Participants randomized to Arm C:~Cycles 1 through 8 - 650 mg administered on Days 1, 8 and 15."
Diphenhydramine
"25 mg administered via IV~Participants randomized to Arm C:~Cycles 1 through 8 - 25 mg administered on Days 1, 8 and 15."
Montelukast
10 mg administered PO to participants randomized to Arm C prior to the first 4 doses of Daratumumab.
Carfilzomib
"20 mg or 56 mg/m2 per dose administered via IV.~Participants randomized to Arm B:~Cycle 1 - 20 mg/m2 per dose on Day 1 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle;~Participants randomized to Arm C:~Cycle 1 - 20 mg/m2 per dose on Day 2 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle"
Daratumumab
"16 mg/kg administered via IV or 1800 mg SC, per treating physician discretion.~Participants randomized to Arm C:~Cycles 1 though 2 - 16 mg/kg IV or 1800 mg SC on days 1, 8, 15, and 22 of a 28 day cycle; Cycles 3 through 6- 16 mg/kg IV or 1800 mg SC on days 1 and 15 of a 28 day cycle; Cycles 7 through 8 - 16 mg/kg IV or 1800 mg SC on day 1 of a 28 day cycle"
Autologous Stem Cell Transplant (ASCT)
Participants who are MRD positive at the conclusion of 8 cycles of study treatment, and were able to have their stem cells that were extracted, will receive ASCT from participants' bone marrow samples.
Memorial Sloan Kettering Cancer Center, New York
Stony Brook University, Stony Brook
Roswell Park Comprehensive Cancer Center, Buffalo
University of Miami, Miami
MD Anderson Cancer Center, Houston
Huntsman Cancer Institue, Salt Lake City
Moffitt Cancer Center, Tampa
Collaborators (2)
Amgen
INDUSTRY
Janssen Pharmaceuticals
INDUSTRY
University of Miami
OTHER