{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.8","upperLimit":"90.6","value":"33.3"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"0","value":"0"},{"groupId":"OG002","lowerLimit":"0.8","upperLimit":"90.6","value":"33.3"},{"groupId":"OG003","lowerLimit":"9.4","upperLimit":"99.2","value":"66.7"},{"groupId":"OG004","lowerLimit":"2.1","upperLimit":"26.5","value":"10.0"},{"groupId":"OG005","lowerLimit":"21.6","upperLimit":"52.0","value":"35.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"30"},{"groupId":"OG005","value":"42"}],"units":"Participants"}],"description":"Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \\< 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \\>= 90% reduction in serum M-protein plus urine M-protein level \\< 100mg/24 hours; PR: \\>= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by \\>= 90% or to \\<200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of \\>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered with 7 full IV infusion of 4 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG000","title":"Part 1: Daratumumab 4 mg/kg"},{"description":"Participants were administered with 7 full IV infusion of 8 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG001","title":"Part 1:Daratumumab 8 mg/kg"},{"description":"Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab every 2 week (q2w) for 14 weeks, then every 4 weeks (q4w), along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG002","title":"Part 1: Daratumumab 16 mg/kg"},{"description":"Participants were administered with 7 full IV infusion of 24 mg/kg daratumumab once weekly, along with this participants also received methylprednisolone 80 mg IV injection before first 2 infusions and 40 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG003","title":"Part 1:Daratumumab 24 mg/kg"},{"description":"Participants were administered with 8 full IV infusions of 8 mg/kg daratumumab once weekly for 8 weeks, then every 2 weeks (q2w) for 16 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions.","id":"OG004","title":"Part 2: Daratumumab 8 mg/kg"},{"description":"Participants were administered with 8 full IV infusions of 16 mg/kg daratumumab once weekly for 7 weeks, then every 2 weeks (q2w) for 14 weeks, then every 4 weeks (q4w) until the participant experienced disease progression or unmanageable toxicity whichever came first, along with this participants also received methylprednisolone 100 mg IV before treatment and 20-25 mg methylprednisolone orally for 2 days after all full infusions. First 2 infusions were separated by 3 week washout period.","id":"OG005","title":"Part 2: Daratumumab 16 mg/kg"}],"paramType":"NUMBER","populationDescription":"All-Treated Analysis Set included all enrolled participants who received at least 1 dose of study drug. For Part 1, only participants treated with \\>= 4 mg/kg daratumumab were used for efficacy analyses and less than (\\<) 4 mg/kg doses were considered under the therapeutic levels.","reportingStatus":"POSTED","timeFrame":"Up to Week 28 (for Part 1) and Week 27 (for Part 2)","title":"Overall Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}