{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.29","upperLimit":"47.05","value":"42.41"},{"groupId":"OG001","lowerLimit":"58.58","upperLimit":"80.07","value":"66.73"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"350"}],"units":"Participants"}],"description":"Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.","dispersionType":"95% Confidence Interval","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":"ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.","reportingStatus":"POSTED","timeFrame":"From randomization (Day -3) up to 8.3 years","title":"Progression Free Survival on Next Line of Therapy (PFS2)","type":"SECONDARY","unitOfMeasure":"Months"}