{"groups":[{"description":"Ixazomib 0.24 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).","id":"FG000","title":"Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2"},{"description":"Ixazomib 0.48 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).","id":"FG001","title":"Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2"},{"description":"Ixazomib 0.8 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).","id":"FG002","title":"Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2"},{"description":"Ixazomib 1.2 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).","id":"FG003","title":"Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2"},{"description":"Ixazomib 1.68 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).","id":"FG004","title":"Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2"},{"description":"Ixazomib 2.0 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).","id":"FG005","title":"Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2"},{"description":"Ixazomib 2.23 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).","id":"FG006","title":"Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2"},{"description":"Ixazomib 2.0 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).","id":"FG007","title":"Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2"},{"description":"Ixazomib 2.0 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \\>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).","id":"FG008","title":"Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2"},{"description":"Ixazomib 2.0 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \\>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).","id":"FG009","title":"Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2"},{"description":"Ixazomib 2.0 mg/m\\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).","id":"FG010","title":"Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"5"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Withdrawal by Participant"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"comment":"6 participants from 2.0 mg/m\\^2 dose cohort transitioned to dose expansion cohort: 5 in RR, 1 in VR.","groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"7"},{"groupId":"FG006","numSubjects":"4"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Part 1 (Dose Escalation)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"14"},{"groupId":"FG008","numSubjects":"8"},{"groupId":"FG009","numSubjects":"3"},{"groupId":"FG010","numSubjects":"2"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"3"},{"groupId":"FG009","numSubjects":"2"},{"groupId":"FG010","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"5"},{"groupId":"FG008","numSubjects":"1"},{"groupId":"FG009","numSubjects":"1"},{"groupId":"FG010","numSubjects":"0"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"20"},{"groupId":"FG008","numSubjects":"12"},{"groupId":"FG009","numSubjects":"6"},{"groupId":"FG010","numSubjects":"2"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"20"},{"groupId":"FG008","numSubjects":"12"},{"groupId":"FG009","numSubjects":"6"},{"groupId":"FG010","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Part 2 (Dose Expansion)"}],"preAssignmentDetails":"60 participants with a diagnosis of relapsed and/or refractory (RR) multiple myeloma were enrolled in 1 of 7 ixazomib dose escalation groups (26 participants) and/or 1 of 4 ixazomib dose expansion groups (40 participants). 6 Participants in 2.0 mg/m\\^2 dose escalation cohort were also included in the expansion group: 5 in RR, 1 in VR arms.","recruitmentDetails":"Participants took part in the study at 5 investigative sites in the United States from 12 October 2009 to 23 May 2017."}