{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"Fisher's exact test was used to compare the response rates between the two arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.029","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.354","upperLimit":"0.848","value":"0.625"},{"groupId":"OG001","lowerLimit":"0.041","upperLimit":"0.457","value":"0.188"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"description":"CR:\n\nPatients with complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. To be considered CR, patients must meet all of the following criteria:\n\n* Negative immunofixation on the serum and urine at two consecutive times\n* Disappearance of any soft tissue plasmacytomas\n* ≤5% plasma cells in bone marrow\n* If serum and urine M protein are unmeasurable and the immunoglobulin free light chain (FLC) parameter is being used, patients must have a normal ratio of 0.26-1.65 at two consecutive times\n\nVGPR:\n\n* Serum and urine M-component detectable by immunofixation but not on electrophoresis OR\n* \\>=90% reduction in serum M-component plus urine M-component \\<100 mg per 24 hours (by SPEP and UPEP)\n* If the serum and urine M protein are unmeasurable and the immunoglobulin FLC parameter is being used, a \\>90% decrease in the difference between involved and uninvolved FLC levels is required in place of the M protein criteria","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.\n\nbortezomib: Given IV\n\nlenalidomide: Given PO\n\ndexamethasone: Given PO","id":"OG000","title":"Arm A (VRD)"},{"description":"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.\n\nbortezomib: Given IV\n\ndexamethasone: Given PO","id":"OG001","title":"Arm B (VD)"}],"paramType":"NUMBER","populationDescription":"Patients with measurable disease at randomization were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Assessed at the end of each cycle, every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry, up to 10 years","title":"Response Rates (Complete Response [CR] or Very Good Partial Response [VGPR])","type":"SECONDARY","unitOfMeasure":"Proportion of patients"}