{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"22"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. \"Near\" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.","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":"Per protocol, patients who completed the day 80-120 evaluation assessments.","reportingStatus":"POSTED","timeFrame":"Up to 120 days after transplant","title":"CR and Near CR Rates","type":"PRIMARY","unitOfMeasure":"percentage of participants"}