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

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).

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.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• University of Miami

  lead OTHER

Principal Investigators

• Carl Landgren, MD · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-11

Primary Completion

2027-02-01

Completion

2027-02-01

FDA Drug

Yes

Countries

• United States

Study Locations