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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 20, 2024

Primary Completion Date

March 1, 2029

Study Completion Date

March 1, 2031

Conditions
Refractory Multiple MyelomaRelapsed 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)."

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Benjamin T Diamond, MD

OTHER

NCT05896228 - Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma | Biotech Hunter | Biotech Hunter