50
Participants
Start Date
July 1, 2017
Primary Completion Date
October 31, 2026
Study Completion Date
October 31, 2027
Carfilzomib
Given by vein: days 1 and 2 of Induction; days 1, 8, 15, and 22 of Consolidation 1; and days 1, 8, 15, and 22 of alternating 3-month blocks during Maintenance.
Thalidomide
Given by mouth at bedtime: days 1-4 of Induction
Dexamethasone
Given by mouth or by vein: days 1-4 of Induction; days -4 - -1 of Transplant(s); and days 1, 8, 15, and 22 of every cycle during Maintenance
Daratumumab
Given by vein: day -1 of induction; days 1 and 8 of Immunological Consolidations; and day 1 of each Maintenance cycle
Cisplatin
Given by vein: days 1-4 (continuous infusion) of Induction
Adriamycin
Given by vein: days 1-4 (continuous infusion) of Induction
Cyclophosphamide
Given by vein: days 1-4 (continuous infusion) of Induction
Etoposide
Given by vein: days 1-4 (continuous infusion) of Induction
Melphalan
Given by vein: days -4 - -1 of Transplant(s)
ASCT
day 0 of Transplant(s)
Lenalidomide
Given by mouth: days 1-21 of alternating 3-month blocks during Maintenance
Bortezomib
Given by vein or subcutaneous injection: may be substituted for carfilzomib throughout the study regimen at the discretion of the treating physician
University of Arkansas for Medical Sciences, Little Rock
Janssen, LP
INDUSTRY
University of Arkansas
OTHER