{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.6","upperLimit":"21.5","value":"13.3"},{"groupId":"OG001","lowerLimit":"14.9","upperLimit":"27.2","value":"21.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"40"}],"units":"Participants"}],"description":"Time to treatment failure, which is defined as the time from day 0 to the time of progressive disease. Progressive disease is defined by unequivocal objective evidence and constitutes any of the following: 1). an increase in the total amount of monoclonal protein (M-component from Serum Protein Electrophoresis (SPEP) and/or Urine Protein Electrophoresis (UPEP) with immunofixation) by more than 100% from the lowest level of serum myeloma protein seen after high-dose chemotherapy by serum protein electrophoresis; 2). an increase in the total amount of monoclonal protein above the remission level of the myeloma peak (i.e., an increase of \\>25% above the lowest level in a 24 hour urine or serum protein; 3). the reappearance of the M-protein if the patient had entered a CR: 4). definite increase in the size (\\> 1 cm) or number of lytic bone lesions. Compression fractures do not constitute a relapse.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Phase II (treatment at MTD) evaluable participants at time of analysis","reportingStatus":"POSTED","timeFrame":"Phase II - Phase start at 62 months up to 120 months","title":"Phase II Event Free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"months"}