{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.617","upperLimit":"4.000","value":"1.020"},{"groupId":"OG001","lowerLimit":"0.517","upperLimit":"0.517","value":"0.517"},{"groupId":"OG002","lowerLimit":"1.470","upperLimit":"2.030","value":"1.750"},{"groupId":"OG003","lowerLimit":"0.500","upperLimit":"2.170","value":"1.000"},{"groupId":"OG004","lowerLimit":"0.533","upperLimit":"4.000","value":"1.302"},{"groupId":"OG005","lowerLimit":"0.483","upperLimit":"4.000","value":"1.560"},{"groupId":"OG006","lowerLimit":"0.500","upperLimit":"4.000","value":"1.282"},{"groupId":"OG007","lowerLimit":"0.417","upperLimit":"2.150","value":"0.567"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"18"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"5"}],"units":"Participants"}],"title":"Cycle 1, Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.500","upperLimit":"4.000","value":"1.050"},{"groupId":"OG001","lowerLimit":"8.000","upperLimit":"8.000","value":"8.000"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1, Day 11"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"0.583","upperLimit":"2.000","value":"0.833"},{"groupId":"OG003","lowerLimit":"0.500","upperLimit":"4.000","value":"1.000"},{"groupId":"OG004","lowerLimit":"0.500","upperLimit":"0.500","value":"0.500"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"14"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1, Day 15"},{"categories":[{"measurements":[{"groupId":"OG005","lowerLimit":"0.500","upperLimit":"4.030","value":"1.500"},{"groupId":"OG006","lowerLimit":"0.550","upperLimit":"2.000","value":"1.275"},{"groupId":"OG007","lowerLimit":"0.300","upperLimit":"1.430","value":"0.760"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"4"}],"units":"Participants"}],"title":"Cycle 1, Day 29"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"5"}],"units":"Participants"}],"dispersionType":"Full Range","groups":[{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \\[34 months\\]).","id":"OG000","title":"Arm A: Ixazomib 3.0 mg"},{"description":"Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \\[21 months\\]).","id":"OG001","title":"Arm A: Ixazomib 3.7 mg"},{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \\[25 months\\]).","id":"OG002","title":"Arm B: Ixazomib 3.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \\[58 months\\]).","id":"OG003","title":"Arm B: Ixazomib 4.0 mg"},{"description":"Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \\[24 months\\]).","id":"OG004","title":"Arm B: Ixazomib 5.5 mg"},{"description":"Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \\[40 months\\]).","id":"OG005","title":"Arm C: Ixazomib 3.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \\[24 months\\]).","id":"OG006","title":"Arm C: Ixazomib 4.0 mg"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \\[38 months\\]).","id":"OG007","title":"Arm D: Ixazomib 4.0 mg"}],"paramType":"MEDIAN","populationDescription":"The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.","reportingStatus":"POSTED","timeFrame":"Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D","title":"Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)","type":"SECONDARY","unitOfMeasure":"hours"}