{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"57"}]}],"title":"Overall Response Rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"18"}]}],"title":"Complete Response Rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"39"}]}],"title":"Partial Response Rate"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"description":"Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).","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 II (treatment at MTD) participants with responsive disease prior to transplant.","reportingStatus":"POSTED","timeFrame":"Phase II - Phase start at 62 months up to 120 months","title":"Phase II Participants - Overall Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}