{"analyses":[{"ciLowerLimit":"0.052","ciNumSides":"TWO_SIDED","ciPctValue":"80","ciUpperLimit":"0.162","groupDescription":"The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \\>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","paramType":"Difference in response rate between arms","paramValue":"0.107"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.729","upperLimit":"0.842","value":"0.79"},{"groupId":"OG001","lowerLimit":"0.615","upperLimit":"0.745","value":"0.683"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"214"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \\<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).\n\nAs the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.","id":"OG000","title":"Arm I (Lenalidomide, Dexamethasone)"},{"description":"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.","id":"OG001","title":"Arm II (Lenalidomide, Low-dose Dexamethasone)"}],"paramType":"NUMBER","populationDescription":"Only eligible patients were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Assessed every 4 weeks for 16 weeks during Step 1","title":"Proportion of Patients With Objective Response (First Phase, Step 1)","type":"PRIMARY","unitOfMeasure":"Proportion of patients"}