{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"12.6","value":"0.82"},{"groupId":"OG001","lowerLimit":"0.4","upperLimit":"15.5","value":"0.79"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"318"}],"units":"Participants"}],"description":"Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. 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; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \\>=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \\>=30%. In addition to the above criteria, if present at baseline, a \\>=50% reduction in the size of soft tissue plasmacytomas was also required.","dispersionType":"Full Range","groups":[{"description":"Participants received Velcade (bortezomib) 1.3 milligrams per square meter (mg/m\\^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Each treatment cycle was of 6 weeks. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \\[IMWG\\] criteria). After implementation of Amendment 7, post interim overall survival (OS) analysis, sponsor confirmation of disease progression was no longer required prior to initiation of subsequent anti-myeloma therapy, except for participants who progressed on VMP arm and requested subsequent therapy with daratumumab.","id":"OG000","title":"Velcade, Melphalan and Prednisone (VMP)"},{"description":"Participants received Velcade 1.3 mg/m\\^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m\\^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m\\^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then once every 3 weeks in Cycle 2 to 9 and thereafter, once every 4 weeks (post-VMP treatment phase) until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre-medication and prednisone substitute. Each treatment cycle was of 6 weeks. After implementation of Amendment 7, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab SC injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).","id":"OG001","title":"Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)"}],"paramType":"MEDIAN","populationDescription":"Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint.","reportingStatus":"POSTED","timeFrame":"From randomization (Day -3) up to 2.4 years","title":"Time to Response","type":"SECONDARY","unitOfMeasure":"Months"}