{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"79","upperLimit":"98","value":"88"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"}],"units":"Participants"}],"description":"PFS estimated using the product-limit method of Kaplan and Meier. Defined as the percentage of patients progression-free at year one after starting treatment.\n\nInternational Myeloma Working Group uniform response criteria for disease progression:\n\nIncrease of \\> 25% from baseline in Serum M-component and/or (the absolute increase must be \\> 0.5 g/dl); Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h; Only in patients without measurable serum and urine M-protein levels:\n\nthe difference between involved and uninvolved FLC levels. The absolute increase must be \\>l0mg/dl.\n\nBone marrow plasma cell percentage: the absolute % must be \\> 10%C; Definite development of new bone lesions or soft tissue plasmacytomas.\n\nor definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive high-dose melphalan IV 200mg/m\\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.","id":"OG000","title":"Treatment (Stem Cell Transplant, Maintenance Treatment)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From start of treatment initiation until disease progression, relapse or death from any cause, assessed up to 1 year.","title":"One Year Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}