A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

February 11, 2020

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2027

Conditions
Multiple Myeloma
Interventions
DRUG

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.

DRUG

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;"

DRUG

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."

DRUG

Acetaminophen

"650 mg administered PO.~Participants randomized to Arm C:~Cycles 1 through 8 - 650 mg administered on Days 1, 8 and 15."

DRUG

Diphenhydramine

"25 mg administered via IV~Participants randomized to Arm C:~Cycles 1 through 8 - 25 mg administered on Days 1, 8 and 15."

DRUG

Montelukast

10 mg administered PO to participants randomized to Arm C prior to the first 4 doses of Daratumumab.

DRUG

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"

DRUG

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"

BIOLOGICAL

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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

11794

Stony Brook University, Stony Brook

14203

Roswell Park Comprehensive Cancer Center, Buffalo

33136

University of Miami, Miami

77030

MD Anderson Cancer Center, Houston

84113

Huntsman Cancer Institue, Salt Lake City

33612-9497

Moffitt Cancer Center, Tampa

Sponsors
All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

University of Miami

OTHER

NCT04268498 - A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma | Biotech Hunter | Biotech Hunter