{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"3"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:\n\n* Grade 2 neuropathy with pain\n* Any grade 3 Non-Hematologic toxicity\n* Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by \\>14 days.\n* Grade 4 neutropenia\n* Febrile neutropenia\n* Grade 4 thrombocytopenia\n* Grade 3 thrombocytopenia associated with bleeding\n* Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by \\>14 days.\n\nWe are reporting the results of this endpoint as the number of DLTs per dose level.","groups":[{"description":"Bendamustine 50 mg/m\\^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity","id":"OG000","title":"Phase I, Dose Level 1"},{"description":"Bendamustine 50 mg/m\\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity","id":"OG001","title":"Phase I, Dose Level 2"},{"description":"Bendamustine 75 mg/m\\^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity","id":"OG002","title":"Phase I, Dose Level 3"},{"description":"Bendamustine 75 mg/m\\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity","id":"OG003","title":"Phase I, Dose Level 4"},{"description":"Bendamustine 100 mg/m\\^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity","id":"OG004","title":"Phase I, Dose Level 5"}],"paramType":"NUMBER","populationDescription":"All participants registered to the Phase I portion of this study were evaluable for this endpoint.","reportingStatus":"POSTED","timeFrame":"One cycle of treatment","title":"Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)","type":"PRIMARY","unitOfMeasure":"Dose Limiting Toxic Events"}