{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.006","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"groups":[{"description":"Bortezomib, Bendamustine and Dexamethasone\n\nBortezomib: 1.3 mg/m2 subcutaneously\\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).\n\n\\*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib\n\nBendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nDexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle","id":"OG000","title":"Arm A (BBD)"},{"description":"Thalidomide, Bendamustine and Dexamethasone\n\nThalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nBendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)\n\nDexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle","id":"OG001","title":"Arm B (BTD)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The primary endpoint of serum free light chain response was assessed in 30 patients where samples were available at screening and the end of two cycles of trial treatment.","reportingStatus":"POSTED","timeFrame":"End of week 6 (after receiving two cycles of therapy)","title":"Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain","type":"PRIMARY","unitOfMeasure":"Participants"}