{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:\n\n* grade 4 hematologic toxicity without regard for relationship to study drug treatment\n* thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage\n* grade 3 febrile neutropenia\n* grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy\n* any study drug related grade 3 or grade 4 nonhematologic toxicity\n* any drug related death\n\nToxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.","groups":[{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG000","title":"Bendamustine 50 mg/m^2 Cohort"},{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG001","title":"Bendamustine 70 mg/m^2 Cohort"},{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG002","title":"Bendamustine 90 mg/m^2 Cohort"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"Day 1 - 28","title":"Participants With Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"participants"}