{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.20","pValueComment":"The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"176"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"242"}],"units":"Participants"}],"description":"The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.","groups":[{"description":"Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nDexamethasone: Given PO\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nLenalidomide: Given PO","id":"OG000","title":"Arm I (Dexamethasone and Lenalidomide)"},{"description":"Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.\n\nBortezomib: Given IV\n\nDexamethasone: Given PO\n\nLaboratory Biomarker Analysis: Optional correlative studies\n\nLenalidomide: Given PO","id":"OG001","title":"Arm II (Dexamethasone, Lenalidomide, Bortezomib)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All eligible, analyzable patients are included.","reportingStatus":"POSTED","timeFrame":"Up to 6 years","title":"Response Rates ()","type":"SECONDARY","unitOfMeasure":"Participants"}