8
Participants
Start Date
July 10, 2015
Primary Completion Date
March 6, 2018
Study Completion Date
March 6, 2018
JNJ-54767414 (Daratumumab)
JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles.
Bortezomib
Bortezomib will be administered at a dose of 1.3 mg/m\^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered.
Dexamethasone
Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication.
Hiroshima
Hitachi
Nagoya
Shibuya City
Tachikawa
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY