{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70","upperLimit":"78","value":"78"},{"groupId":"OG001","lowerLimit":"41","upperLimit":"62","value":"52"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"Progression is defined as a \\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.\n\nIn patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Lenalidomide+Dexamethasone"},{"description":"Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.","id":"OG001","title":"Dexamethasone"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years","title":"Progression-Free Survival","type":"PRIMARY","unitOfMeasure":"percentage of participants"}