{"groups":[{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG000","title":"1: CFZ 15 mg/m² + LEN 10 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG001","title":"2: CFZ 15 mg/m² + LEN 15 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG002","title":"3: CFZ 15 mg/m² + LEN 20 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG003","title":"4: CFZ 20 mg/m² + LEN 20 mg"},{"description":"Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG004","title":"5: CFZ 20 mg/m² + LEN 25 mg"},{"description":"Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG005","title":"6: CFZ 20/27 mg/m² + LEN 25 mg"},{"description":"In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.","id":"FG006","title":"7: CFZ 20/27 mg/m² + LEN 25 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"10"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"13"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"}],"type":"Withdrew Consent"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"6"},{"groupId":"FG004","numSubjects":"6"},{"groupId":"FG005","numSubjects":"8"},{"groupId":"FG006","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG000","numSubjects":"6"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG001","numSubjects":"3"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG002","numSubjects":"6"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG003","numSubjects":"4"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG004","numSubjects":"1"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG005","numSubjects":"6"},{"comment":"Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.","groupId":"FG006","numSubjects":"20"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"5"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"24"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In the dose-escalation portion, participants were enrolled in sequential cohorts to determine the maximum tolerated doses (MTD) of carfilzomib and lenalidomide. In the expansion portion either the MTD or the maximum planned dose (MPD) from Cohort 6 (if no MTD was determined) was administered to gain additional safety and efficacy information.","recruitmentDetails":"This was an open-label study of carfilzomib (CFZ) given in combination with lenalidomide (LEN) and low-dose dexamethasone (DEX) in patients with relapsed multiple myeloma. The study consisted of a dose-escalation portion and an expansion portion. Participants were treated until disease progression (PD) or unacceptable toxicity."}