NCT04268498

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

Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to find out whether carfilzomib, lenalidomide, and dexamethasone (KRD) or KRD and Daratumumab (KRD+DARA) might be safer and more effective ways of controlling multiple myeloma than the standard of care treatment, which is lenalidomide, bortezomib, and dexamethasone (VRD).

Detailed description

Per protocol amendment version 4.0 (May 23, 2022), Arm A will be closed and no additional participants will be enrolled in this arm.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-11
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2020-02-13
• Last updated: 2026-03-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study