57
Participants
Start Date
October 5, 2020
Primary Completion Date
May 2, 2024
Study Completion Date
May 2, 2026
Daratumumab
"Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).~Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36)~Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88)~Sites will continue to use IV daratumumab to treat existing study patients until the IV daratumumab stock on site has been exhausted. The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.~Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1"
Lenalidomide
"Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24)~Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36)~Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance~Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression"
Bortezomib
Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)
Dexamethasone
Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
University of Rochester, Rochester
University of Michigan Rogel Cancer Center, Ann Arbor
Barbara Ann Karmanos Cancer Institute, Detroit
University of Texas Southwestern -- Simmons Comprehensive Cancer Center, Dallas
Janssen Scientific Affairs, LLC
INDUSTRY
University of Michigan Rogel Cancer Center
OTHER