{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.045","estimateComment":"Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.","groupDescription":"Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","paramType":"Hazard Ratio (HR)","paramValue":"0.84"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.2","upperLimit":"27.5","value":"21.0"},{"groupId":"OG001","lowerLimit":"16.0","upperLimit":"22.1","value":"18.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"152"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the earlier of progression or death of any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).\n\nINDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.","id":"OG000","title":"Arm I (MPT-T)"},{"description":"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).\n\nINDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.","id":"OG001","title":"Arm II (mPR-R)"}],"paramType":"MEDIAN","populationDescription":"Intention-to-treat (ITT) population","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.","title":"Progression-Free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}