{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"231"}],"units":"Participants"}],"description":"Relapse is defined by the unequivocal objective evidence of recurrent disease such as:\n\nmyeloma-related cytogenetic abnormalities; bone marrow plasmacytosis \\>10% or \\>5% light chain restricted, non-diploid, plasma cells on clg/DNA; new skeletal or MRI lesions; hypercalcemia not explained by any other cause; or reappearance of M-protein in blood or urine not related to immune recovery, recent infection, and present for \\>2 months.","groups":[{"description":"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.\n\nVAD: 3 Cycles (3rd cycle optional):\n\nVincristine 0.5 mg/d d 1 - 4 CI Adriamycin 10 mg/m2/d d 1 - 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20\n\nHigh-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:\n\nCytoxan 1.2g/m2/d d 1 - 5 Mesna 3.6 g/m2 d 1\n\nHemopoietic stem cell procurement: Collection target = 10 x 10\\^6 cells/kg\n\nEDAP: Approximately 5-6 weeks after high-dose cyclophosphamide","id":"OG000","title":"Study Treatment"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"5 years","title":"Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy","type":"PRIMARY","unitOfMeasure":"percentage of participants"}