Study: NCT04268498

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 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;

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 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;

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 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;

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acetaminophen
Description: 650 mg administered PO.~Participants randomized to Arm C:~Cycles 1 through 8 - 650 mg administered on Days 1, 8 and 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Diphenhydramine
Description: 25 mg administered via IV~Participants randomized to Arm C:~Cycles 1 through 8 - 25 mg administered on Days 1, 8 and 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Montelukast
Description: 10 mg administered PO to participants randomized to Arm C prior to the first 4 doses of Daratumumab.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carfilzomib
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carfilzomib
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Daratumumab
Description: 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

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Stem Cell Transplant (ASCT)
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Stem Cell Transplant (ASCT)
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Stem Cell Transplant (ASCT)
Description: 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.