{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}],"title":"CR"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"VGPR"},{"measurements":[{"groupId":"OG000","value":"6"}],"title":"PR/SD"},{"measurements":[{"groupId":"OG000","value":"6"}],"title":"PD"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"units":"Participants"}],"description":"Response gradations are specified in the \"Blade criteria\", Br J Haematol 1998; 102: 1115-1123. Serum myeloma protein is measured 2x at least six weeks apart, and urine M-component is measured 2x at least 3 weeks apart. Complete response (CR): less than 3% plasma cells in bone marrow or blood. Very good partial response (VGPR): Greater than 90% decrease in myeloma protein, and urine M-component less than 0.1 gm/day. Partial response (PR) Greater than 50% decrease in myeloma protein; urine M-component less than 0.2 gm/day. Lytic skeletal lesions must not increase, and serum calcium level must remain normal. Stable disease (SD): 25-49% decrease in protein and 25% decrease in urine M-component. Progressive disease (PD): Greater than 25% increase in myeloma protein, or hypercalcemia. Relapse: 1) increase greater than 100% of myeloma protein; 2) More than 25% increase of myeloma protein; 3) reappearance of the myeloma peaks; 4) increase in lytic bone lesions on radiographs.","groups":[{"description":"Patients receive high-dose melphalan IV on day -1. PBSCs are reinfused on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Between 8 and 14 weeks later, patients receive high-dose busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. PBSCs are reinfused on day 0 and G-CSF is administered IV or SC daily until blood counts recover.\n\nfilgrastim\n\nrecombinant interferon alfa\n\nbusulfan\n\ncyclophosphamide\n\nmelphalan\n\npamidronate disodium\n\nthalidomide\n\nperipheral blood stem cell transplantation","id":"OG000","title":"HD Chemo Followed by PBPC Rescue"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Response after six months after day 0 of the first cycle of the tandem transplant, after administration of maintenance thalidomide if necessary, until three years post-day 0 of the first cycle of the tandem transplant.","title":"Best Response After Tandem Autologous Stem Cell Transplant and Maintenance","type":"PRIMARY","unitOfMeasure":"Participants"}