101
Participants
Start Date
November 9, 2016
Primary Completion Date
March 8, 2018
Study Completion Date
August 17, 2020
Daratumumab
"For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.~Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.~Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks."
Cyclophosphamide
Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m\^2 ) on Days 1, 8, 15, and 22 for every 28 days.
Bortezomib
Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.
Dexamethasone
Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).
Mobile
Phoenix
Sedona
Tucson
Fayetteville
Greenbrae
Denver
Niles
Indianapolis
Louisville
Bethesda
Columbia
Grand Rapids
Omaha
Camden
Albany
East Setauket
Fresh Meadows
Cincinnati
Eugene
Greenville
Austin
Dallas
San Antonio
Tyler
Seattle
Janssen Scientific Affairs, LLC
INDUSTRY