75
Participants
Start Date
February 13, 2019
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
Daratumumab
"Daratumumab (16 mg/kg) will be administered as an IV infusion:~* Cycle 1-2: 16 mg/kg weekly~* Cycles 3-8: 16 mg/kg IV infusion every 2 weeks~* Cycles 9-24: 16 mg/kg IV infusion Day 1"
Carfilzomib
"Carfilzomib will be given as an IV infusion over 30 minutes:~* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8, 9 of cycle 1) will be allowed at the treating physician's discretion.~* Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16~* Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16"
Lenalidomide
"Lenalidomide will be taken orally as follows:~• Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21"
Dexamethasone
"Dexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows:~* Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week~* Cycles 9-24: 20 mg PO per week~During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after~During weeks with no daratumumab, single dose of 20 mg on day 1"
The University of Chicago, Chicago
Collaborators (1)
Janssen Scientific Affairs, LLC
INDUSTRY
Amgen
INDUSTRY
University of Chicago
OTHER