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Treatment at Maintenance Cycle 12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.4","upperLimit":"2.5","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"title":"Change in Side Effects of Treatment at Maintenance Cycle 18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.8","upperLimit":"2.4","value":"-2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"title":"Change in Side Effects of Treatment at Maintenance Cycle 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"}],"units":"Participants"}],"description":"Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.","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":"MEAN","populationDescription":"Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).","reportingStatus":"POSTED","timeFrame":"Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.","title":"Mean Change in Quality-Of-Life Indicators Post-Transplant","type":"SECONDARY","unitOfMeasure":"score on a scale"}