7
Participants
Start Date
September 30, 2016
Primary Completion Date
October 31, 2017
Study Completion Date
March 31, 2020
Daratumumab (16 mg/kg)
Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Lenalidomide
Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours.
Dexamethasone
Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle.
Hiroshima
Kanazawa
Nagoya
Osaka
Shibuya City
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY