{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"sCR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"CR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"VGPR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"PR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"SD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"PD"}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"}],"units":"Participants"}],"description":"The primary endpoint for the phase 2 portion of this study is to determine the duration of overall response (DoR). The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).","groups":[{"description":"Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN.\n\nIn Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1.\n\nAfter a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG000","title":"Phase 2 Expansion"}],"paramType":"NUMBER","populationDescription":"This outcome measure only assesses Phase 2 participants","reportingStatus":"POSTED","timeFrame":"Until disease progression, death, or for a maximum of 3 years, whichever occurs first","title":"Duration of Overall Response (DoR)","type":"PRIMARY","unitOfMeasure":"participants"}