{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"127.8"},{"groupId":"OG001","value":"30"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"60"}],"units":"Participants"}],"description":"MTD of topotecan in multiple myeloma patients receiving autologous transplant when give with melphalan 150 mg/m\\^2 for three days. Two parallel dose escalations were used, one each for young (18-60 years of age) and elderly patients (\\> 61 years of age). Elderly patients began a dose level once it had been found to be safe for the young cohort. The purpose of this approach was to expand the access of this trial to elderly patients while ensuring safety.\n\nPhase I Dose Escalation: Level 1 - 20 mg/m\\^2; Level 2 - 30 mg/m\\^2; Level 4 - 54 mg/m\\^2; Level 5 - 72 mg/m\\^2; Level 6 - 96 mg/m\\^2; Level 7 - 127.8 mg/m\\^2; Level 8 - 170.1 mg/m\\^2","groups":[{"description":"Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.\n\nmelphalan: (Days -4,-3,-2) 50 mg/m\\^2/day IV over 30 minutes (total dose 150 mg/m\\^2)\n\ntopotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\\^2; Level 2 - 30 mg/m\\^2; Level 4 - 54 mg/m\\^2; Level 5 - 72 mg/m\\^2; Level 6 - 96 mg/m\\^2; Level 7 - 127.8 mg/m\\^2; Level 8 - 170.1 mg/m\\^2\n\nPhase II: Treatment at maximum tolerated dose (MTD)\n\nAutologous Stem Cell Rescue: Day 0","id":"OG000","title":"Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue"},{"description":"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.\n\nmelphalan: (Days -4,-3,-2) 50 mg/m\\^2/day IV over 30 minutes (total dose 150 mg/m\\^2)\n\ntopotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\\^2; Level 2 - 30 mg/m\\^2; Level 4 - 54 mg/m\\^2; Level 5 - 72 mg/m\\^2; Level 6 - 96 mg/m\\^2; Level 7 - 127.8 mg/m\\^2; Level 8 - 170.1 mg/m\\^2\n\nPhase II: Treatment at maximum tolerated dose (MTD)\n\nAutologous Stem Cell Rescue: Day 0","id":"OG001","title":"Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue"}],"paramType":"NUMBER","populationDescription":"Phase I Dose Escalation participants.","reportingStatus":"POSTED","timeFrame":"Phase I - 5 years, 2 months","title":"Phase I - Maximum Tolerated Dose (MTD) Level","type":"PRIMARY","unitOfMeasure":"mg/m^2"}