{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Pomalidomide"},{"categories":[{"measurements":[{"groupId":"OG000","value":"120"}]}],"title":"Bendamustine"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"}],"units":"Participants"}],"description":"In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.\n\nCohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)\n\nIf dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).","groups":[{"description":"* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days\n* Bendamustine: once intravenous (IV) dosing on day 1, every 28 days\n* Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days\n\nStudy treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)\n\nBendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.\n\nPomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.\n\nDexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,","id":"OG000","title":"Cohorts 1 and 2"}],"paramType":"NUMBER","populationDescription":"All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.","reportingStatus":"POSTED","timeFrame":"2 cycles (approximately 2 months)","title":"Maximum Tolerated Dose of Pomalidomide and Bendamustine","type":"PRIMARY","unitOfMeasure":"milligrams"}