RecruitingPhase 2NCT05896228

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

Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma


Sponsor

Benjamin T Diamond, MD

Enrollment

30 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a four-drug combination — iberdomide, daratumumab, carfilzomib, and dexamethasone — in people with multiple myeloma (a blood cancer) that has returned or stopped responding to treatment. **You may be eligible if...** - You have multiple myeloma that got worse during or within 60 days of your last treatment - You have received 1–3 prior lines of therapy, including a lenalidomide-containing regimen - Your myeloma can be measured through blood or urine tests - Your blood counts, kidneys, and liver are in acceptable ranges **You may NOT be eligible if...** - You have had no prior treatment for myeloma - You have had more than 3 prior lines of therapy - You have significant heart, liver, or kidney problems - You are pregnant or not using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIberdomide

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

DRUGCarfilzomib

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.

DRUGDaratumumab

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.

DRUGDexamethasone

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.

DRUGAcetaminophen

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.

DRUGDiphenhydramine

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.

DRUGMontelukast

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).


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05896228


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