{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"7"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\\^3 and platelet count of 20,000/mm\\^3 untransfused by Day 35 post-transplant.","groups":[{"description":"Dose Level 1; Bendamustine 30 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 30 mg/m\\^2 given on day 2 of melphalan\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)","id":"OG000","title":"Dose Level 1"},{"description":"Dose Level 2; Bendamustine 60 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 2nd day of melphalan","id":"OG001","title":"Dose Level 2"},{"description":"Dose Level 3; Bendamustine 90 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 2nd day of melphalan","id":"OG002","title":"Dose Level 3"},{"description":"Dose Level 4; Bendamustine 120 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 1st and 2nd day of melphalan","id":"OG003","title":"Dose Level 4"},{"description":"Dose Level 5; Bendamustine 150 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 1st day of melphalan and 60 mg/m\\^2 given on the 2nd day of melphalan","id":"OG004","title":"Dose Level 5"},{"description":"Dose Level 6; Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan","id":"OG005","title":"Dose Level 6"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).","reportingStatus":"POSTED","timeFrame":"35 days post-transplant","title":"Maximum Tolerated Dose (Phase 1)","type":"PRIMARY","unitOfMeasure":"Participants"}