{"groups":[{"description":"Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.","id":"FG000","title":"Arm A: Active Monitoring (ACTM)"},{"description":"Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).","id":"FG001","title":"Arm B: Daratumumab SC"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"15"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"12"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Randomized in error"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Randomized but not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"145"},{"groupId":"FG001","numSubjects":"163"}],"type":"Ongoing followup"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Principal Investigator and participant decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"194"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"193"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"194"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Results are currently reported until the primary completion date (01 May 2024). Results of remaining duration will be posted upon study completion."}