{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}],"title":"CR+PR"},{"measurements":[{"groupId":"OG000","value":"9"}],"title":"Non-CR+PR"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Missing"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"Overall response rate (CR+PR) of bendamustine in association with bortezomib and pegylated liposomal doxorubicin was assessed in patients with relapsed or refractory Multiple Myeloma. Per modified International Myeloma Working Group criteria: Complete Response (CR) : Negative for monoclonal protein by immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas, and \\<5% plasma cells in bone marrow ; PR : 50% or more reduction in serum M-protein and 90% or more reduction in urine M-protein or to \\<200 mg/24hours or a 50% or more reduction in free light chain level ; Overall Response (OR) = CR +PR.","groups":[{"description":"Bendamustine:\n\nAt phase II, Bendamustine will be administered at 90mg/m\\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle.\n\nDoxorubicin:\n\nPegylated liposomal doxorubicin at phase II will be administered at 30 mg/m2 by IV over 1 hour,at day 4 of the 28 day treatment cycle.\n\nBortezomib:\n\nBortezomib at Phase II will be administered at 1.3 mg/m2 by IV bolus or SQ injection on days 1, 4, 8, and 11 of the 28 day cycle.","id":"OG000","title":"Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin."}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Two subjects never received treatment. Therefore, they were not included in any assessment of objectives.","reportingStatus":"POSTED","timeFrame":"From C1D1 up to a maximum of 52 months or until death","title":"Phase II : Overall Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}