{"classes":[{"categories":[{"measurements":[{"comment":"The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.","groupId":"OG000","value":"NA"},{"comment":"The maximum tolerated dose (MTD) of temsirolimus was not determined because the study was terminated early due to slow accrual.","groupId":"OG001","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment.","groups":[{"description":"Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone)"},{"description":"Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Assessed during cycle 1 (28 days)","title":"Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone","type":"PRIMARY","unitOfMeasure":"mg"}