{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"24"}]}],"title":"Number of patients had at least one adverse event of any grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"19"}]}],"title":"Number of patients had at least one grade 3 or greater adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"14"}]}],"title":"Number of patients had at least one grade 3 or greater treatment related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"8"}]}],"title":"Number of patients having serious adverse event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"description":"Toxicity profile (for all patients) were presented by rate of overall toxicity and rates of grade 3 or 4 toxicities analyzed separately and combined.","groups":[{"description":"Bendamustine: At Phase I level I, 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 90mg/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 120mg/m^2 With Bortezomib and Pegylated Liposomal Doxorubicin."},{"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":"OG002","title":"Phase II : Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin."}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Two subjects in phase II never received treatment. Therefore, they were not included in any assessment of objectives.","reportingStatus":"POSTED","timeFrame":"From C1D1 until death or up to a maximum of 54 months","title":"Phase I & Phase II : Toxicity of Treatment Regimen","type":"SECONDARY","unitOfMeasure":"Participants"}