{"analyses":[{"groupDescription":"In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \\</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \\>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.","groupIds":["OG000"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.","pValue":"0.69","statisticalMethod":"Two stage design, exact method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"19","value":"4.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"Very-good-partial-response-or-better rate is the percentage of participants with complete response (CR) or very good partial response (VGPR) on to the combination of everolimus/bortezomib/rituximab. The combination regimen was received for up to 6 cycles.\n\nCR:\n\n* Absence of serum monoclonal IgM protein by immunofixation\n* Normal serum IgM level\n* Complete resolution of extramedullary disease, i.e., lymphadenopathy and splenomegaly if present at baseline\n* Morphologically normal bone marrow aspirate and trephine biopsy\n\nVGPR:\n\n* Monoclonal IgM protein is detectable ≥90% reduction in serum IgM level from baseline\\*\n* Complete resolution of extramedullary disease, i.e.","dispersionType":"95% Confidence Interval","groups":[{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG000","title":"Phase II"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 6 cycles (Day 168)","title":"Very-good-partial-response-or-better Rate [Phase II]","type":"PRIMARY","unitOfMeasure":"percentage of participants"}