{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\\^2 for the first cycle and 36 mg/m\\^2 for subsequent cycles.","groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Dose Level","paramValue":"1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"7"}],"units":"Participants"}],"description":"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.\n\nFor this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.\n\nWe are reporting the number of DLTs","groups":[{"description":"Patients receive:\n\nOral 300 mg/m\\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.\n\nPatients also recieve 15 mg/m\\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m\\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.","id":"OG000","title":"Phase I: Dose Level -1"},{"description":"Patients receive:\n\nOral 300 mg/m\\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.\n\nPatients also recieve 20 mg/m\\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m\\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.","id":"OG001","title":"Phase I: Dose Level 0"},{"description":"Patients receive:\n\nOral 300 mg/m\\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.\n\nPatients also recieve 20 mg/m\\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m\\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.","id":"OG002","title":"Phase I: Dose Level 1"},{"description":"Patients receive:\n\nOral 300 mg/m\\^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.\n\nPatients also recieve 20 mg/m\\^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m\\^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles.","id":"OG003","title":"Phase I: Dose Level 2"}],"paramType":"NUMBER","populationDescription":"All patients registered to a dose escalation Phase I group were analyzed for this endpoint.","reportingStatus":"POSTED","timeFrame":"From baseline to end of active treatment, up to 12 28-day cycles.","title":"Maximum Tolerated Dose (Phase I)","type":"PRIMARY","unitOfMeasure":"participants"}