{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"units":"Participants"}],"description":"Determine the rate of conversion to complete response (CR). CR requires all of the following:\n\n* Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.\n* Less than 5% plasma cells in the bone marrow on at least 2 determinations. Repeat bone marrow is not required for patients with secretory myeloma who have sustained absence of monoclonal protein on immunofixation.\n* No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).\n* Disappearance of all soft tissue plasmacytomas.\n* Patients in whom some, but not all the criteria for CR are fulfilled are classified as nCR or PR or VGPR (see below), providing the remaining criteria for nCR, VGPR, or PR are satisfied.","groups":[{"description":"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the \"dosimetric\" infusion and the \"therapeutic\" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.","id":"OG000","title":"Bexxar Therapeutic"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"6 months","title":"Number of Participants With Complete Response (CR)","type":"SECONDARY","unitOfMeasure":"participants"}