{"classes":[{"categories":[{"measurements":[{"comment":"1-sided 95% confidence interval reported. Study designed to test whether regimen would increase PFS using 1-sided test at 5% significance level. In accordance with statistical hypothesis,1-sided 95% confidence interval is reported. The form does not provide option for 1-sided confidence interval; only options for 2-sided confidence intervals. Since a 1-sided confidence interval only has 1 bound, NA entered for the upper bound because there is no upper bound.","groupId":"OG000","lowerLimit":"43.6","upperLimit":"NA","value":"76.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"}],"units":"Participants"}],"description":"PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value.","dispersionType":"95% Confidence Interval","groups":[{"description":"Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.\n\nAfter collection, participants will receive dexamethasone x 4 days every 14 days.\n\nTransplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.\n\nOnce recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.\n\nConsolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide)\n\nMaintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.\n\ndexamethasone: Given PO\n\ncisplatin: Given IV\n\ndoxorubicin: Given IV\n\ncyclophosphamide: Given IV or PO\n\netoposide: Given IV\n\nbortezomib: Given IV\n\nthalidomide: Given PO\n\nmelphalan: Given IV\n\nautologous stem cell transplant","id":"OG000","title":"Autologous Stem Cell Transplant"}],"paramType":"MEDIAN","populationDescription":"Participants who have had at least one day of protocol treatment.","reportingStatus":"POSTED","timeFrame":"From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.","title":"Median Progression Free Survival (mPFS)","type":"PRIMARY","unitOfMeasure":"months"}