{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}]}],"title":"Stringent complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"9"}]}],"title":"Complete Reponse"},{"categories":[{"measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"40"}]}],"title":"Very Good Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"88"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"106"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"16"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"17"}]}],"title":"Not Evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"281"},{"groupId":"OG001","value":"278"}],"units":"Participants"}],"description":"The ORR together with the relative proportions in each response category (ie, stringent CR \\[sCR\\], CR, very good PR \\[VGPR\\], PR, SD, and PD) by treatment using the IMWG criteria will be examined.\n\nComplete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow\n\nSCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence\n\nVGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level \\< 100 mg per 24 hours\n\nPR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \\< 200 mg per 24 hours\n\nProgressive Disease: Please refer to Primary outcome measure for definition\n\nSD: Not meeting criteria for CR, VGPR, PR, or progressive disease","groups":[{"description":"POM (Pomalidomide)\n\n* 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"OG000","title":"Treatment 1: POM+BTZ+LD-DEX"},{"description":"BTZ ((Bortezomib)\n\n* For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle\n* For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)\n* For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.\n* For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (\\> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.","id":"OG001","title":"Treatment 2: BTZ+LD-DEX"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months","title":"Overall Response Rate by Independent Response Adjudication Committee (IRAC)","type":"SECONDARY","unitOfMeasure":"Participants"}