{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"description":"Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.","groups":[{"description":"INDUCTION THERAPY:\n\nPatients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.\n\nAUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.\n\nPatients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.\n\nPatients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.","id":"OG000","title":"Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)"},{"description":"INDUCTION THERAPY:\n\nPatients receive amifostine as in arm I and melphalan as in arm I at a lower dose.\n\nAUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.\n\nPatients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.\n\nPatients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.","id":"OG001","title":"Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)"}],"paramType":"NUMBER","populationDescription":"Patients who were treated per protocol.","reportingStatus":"POSTED","timeFrame":"Up to day 56 after transplant","title":"Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2","type":"SECONDARY","unitOfMeasure":"Grade 3-4 adverse events"}