{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"CR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"VGPR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"PR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Objective Response (CR+VGPR+PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"MR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Clinical Benefit (CR+VGPR+PR+MR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Estable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Progressive disease"}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.","groups":[{"description":"40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.","id":"OG000","title":"DVD-R Single Arm"}],"paramType":"NUMBER","populationDescription":"Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria \\[complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)\\]","reportingStatus":"POSTED","timeFrame":"Up to 7.5 months (eight 28-day cycles)","title":"International Myeloma Working Group (IMWG) Response Criteria","type":"PRIMARY","unitOfMeasure":"participants"}