Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

Summary

The investigators want to find out whether or not giving patients who have relapsed or refractory multiple myeloma (MM) the experimental medication combination iberdomide, carfilzomib, daratumumab, and dexamethasone (Iber-KDd) may produce better results than the current (standard of care) treatments. This study will examine the tolerability and efficacy of this combination therapy for all participants and the ability of this combination therapy to shrink or prevent MM from returning.

Conditions

• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Interventions

DRUG

Iberdomide

Participants will receive Iberdomide (Iber) therapy orally (PO) in capsules as follows: * Combination therapy: Cycles 1 to 8: 1 mg per day\*, Days 1 to 21 every 28 days. * Monotherapy: Cycles 9 to 20: 1 mg per day\*, Days 1 to 21 every 28 days. (\*) The first 6 patients will begin at 1 mg/day as lead-in with option to increase to 1.3 mg with dose-escalation cohort after two (2) cycles tolerated therapy

DRUG

Carfilzomib

Participants will receive Carfilzomib (K) therapy intravenously (IV) as follows: * Cycle 1: 20 mg/m2 per dose on Day 1; 56 mg/m2 per dose on Days 8 and 15 * Cycles 2 to 8: 56 mg/m2 per dose on Days 1, 8, and 15.

DRUG

Daratumumab

Participants will receive Daratumumab (D) therapy subcutaneously (SC) or intravenously (IV) as follows: * Cycles 1 and 2: 1800 mg SC or 16 mg/kg IV on Days 1, 8, 15, and 22 * Cycles 3 through 6: 1800 mg SC or 16 mg/kg IV on Days 1 and 15 * Cycles 7 and 8: 1800 mg SC or 16 mg/kg IV on Day 1.

DRUG

Dexamethasone

Participants will receive Dexamethasone (d) therapy either orally (PO) or intravenously (IV) as follows: * Cycles 1 and 2: 40 mg/dose on Days 1, 8, and 15; 20 mg/dose on Day 22 * Cycles 3 and 4: 40 mg/dose on Days 1, 8, and 15 * Cycles 5 through 8: 20 mg/dose on Days 1, 8, and 15.

DRUG

Acetaminophen

Participants will receive Acetaminophen orally (PO) prior to Iber-KDd therapy as follows: * Cycles 1 and 2: 650 mg/dose on Days 1, 8, 15, and 22 * Cycles 3 through 6: 650 mg/dose on Days 1 and 15 * Cycles 7 and 8: 650 mg/dose on Day 1.

DRUG

Diphenhydramine

Participants will receive Diphenhydramine either orally (PO) or intravenously (IV) prior to Iber-KDd therapy as follows: * Cycles 1 and 2: 25 mg/dose on Days 1, 8, 15, and 22 * Cycles 3 through 6: 25 mg/dose on Days 1 and 15 * Cycles 7 and 8: 25 mg/dose on Day 1.

DRUG

Montelukast

Participants will receive Montelukast orally (PO) prior to Iber-KDd as follows: * Cycle 1 only: 10 mg/dose, Days 1, 8, 15, and 22, to be administered prior to the first 4 doses of Daratumumab (D).

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Benjamin T Diamond, MD

  lead OTHER

Principal Investigators

• Carl O Landgren, MD, PhD · University of Miami

• Benjamin Diamond, MD · University of Miami

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-20

Primary Completion

2029-03-01

Completion

2031-03-01

FDA Drug

Yes

Countries

• United States

Study Locations