{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalComment":"Probability from Wilcoxon rank sum test","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.0"},{"groupId":"OG001","value":"4.0"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42.6"},{"groupId":"OG001","value":"19.4"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28.4"},{"groupId":"OG001","value":"56.6"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.4"},{"groupId":"OG001","value":"14.3"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.5"},{"groupId":"OG001","value":"5.7"}]}],"title":"Not Evaluable (NE) those without response data"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.","groups":[{"description":"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"},{"description":"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.\n\nParticipants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.\n\nAfter the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.","id":"OG001","title":"Placebo Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Intent to Treat Population includes all participants who were randomized","reportingStatus":"POSTED","timeFrame":"Randomization to data cut-off of 02 Mar 2008; up to 51 months","title":"Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}