737
Participants
Start Date
February 16, 2015
Primary Completion Date
September 24, 2018
Study Completion Date
October 2, 2024
Daratumumab IV
Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
Lenalidomide
Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.
Dexamethasone
Dexamethasone 40 mg orally or intravenously once in a week.
Daratumumab SC
Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
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