30
Participants
Start Date
February 20, 2024
Primary Completion Date
March 1, 2029
Study Completion Date
March 1, 2031
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"
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."
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."
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."
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."
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."
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)."
RECRUITING
University of Miami, Miami
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Benjamin T Diamond, MD
OTHER