{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"120"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"In the first phase, MTD of bendamustine was determined in combination with bortezomib and pegylated liposomal doxorubicin to gain a better idea of safe dosing before proceeding with the second phase to assess efficacy. Assuming myelosuppression being a dose-limiting effect that could have been overcome with growth factor support, MTD of the combination with myeloid growth factor support was also tested.","groups":[{"description":"Bendamustine: At Phase I level 1, Bendamustine will be administered at 90 mg/m\\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle.\n\nFilgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \\>1000.\n\nDoxorubicin:\n\nPegylated liposomal doxorubicin at phase I 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 I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.","id":"OG000","title":"Phase I Level 1:Bendamustine at 90 mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin."},{"description":"Bendamustine: At Phase I level 2, Bendamustine will be administered at 120 mg/m\\^2 by IV over 1 hour at days 1 and 4 of the 28 day treatment cycle.\n\nFilgrastim (if defined in MTD) will be administered at 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \\>1000.\n\nDoxorubicin:\n\nPegylated liposomal doxorubicin at phase I 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 I will be administered at 1.3 mg/m2 by IV bolus on days 1, 4, 8, and 11 of the 28 day cycle.","id":"OG001","title":"Phase I Level 2:Bendamustine at 120 mg/m^2 With Bortezomib and Pegylated Liposomal"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From C1D1 up to a maximum of 7 months or until death","title":"Phase I: MTD of Bendamustine When Combined With Bortezomib and Pegylated Liposomal Doxorubicin.","type":"PRIMARY","unitOfMeasure":"mg/m^2"}