{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"The MTD of Everolimus/Bortezomib/Rituximab combination is determined by the number of patients who have dose limiting toxicity (DLT). See DLT primary outcome measure for definition. MTD is defined as the highest dose where \\<1/3 participants experience a DLT. If no DLT's are observed on Level 1, 3 subjects will be enrolled in the Level 2. If \\>1/3 subjects in a cohort have DLT, that dose will not be considered safe, with no escalation (MTD exceeded). If 1/3 subjects experience DLT, the cohort will be expanded to 6 subjects. If \\<2 subjects with a DLT among the expanded cohort of 6 evaluable subjects a cohort of 3 subjects will be enrolled in the next higher dose level. If 2 or more subjects with a DLT among the expanded cohort of 6 subjects, that dose level will not be considered safe, no escalation (MTD exceeded).If no DLT's observed, then the MTD is not reached. The MTD was not reached with 0/3 participants experiencing a DLT in the highest level. Higher doses were not planned/tested.","groups":[{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nLevel 1: Everolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nLevel 2 and Dose Expansion: Everolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nLevel 1 \\& 2 and Dose Expansion: Rituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nLevel 1 \\& 2 and Dose Expansion: Bortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG000","title":"Phase I Stage B Level 1 & 2 and Dose Expansion"}],"paramType":"NUMBER","populationDescription":"In Phase I Stage B Level 1, one participant was replaced as an exception granted to the principal investigator having experienced a dose delay due to an adverse event not deemed a DLT.","reportingStatus":"POSTED","timeFrame":"Assessed within the first cycle (28 days) of the study.","title":"Everolimus Maximum Tolerated Dose (MTD) Stage B [Phase I]","type":"PRIMARY","unitOfMeasure":"mg"}