{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42","upperLimit":"100","value":"86"},{"groupId":"OG001","lowerLimit":"9","upperLimit":"99","value":"67"},{"groupId":"OG002","lowerLimit":"29","upperLimit":"100","value":"100"},{"groupId":"OG003","lowerLimit":"43","upperLimit":"84","value":"65"},{"groupId":"OG004","lowerLimit":"15","upperLimit":"95","value":"60"},{"groupId":"OG005","lowerLimit":"5","upperLimit":"85","value":"40"},{"groupId":"OG006","lowerLimit":"9","upperLimit":"99","value":"67"},{"groupId":"OG007","lowerLimit":"7","upperLimit":"93","value":"50"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"23"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"4"}],"units":"Participants"}],"description":"ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \\>reduction in serum M-protein + urine M-protein level \\< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"The response-evaluable population is defined as participants who received at least 5 of 8 MLN9708 doses in Arm A, at least 2 of 3 MLN9708 doses in Arm B, at least 4 of 5 MLN9708 doses in Arm C, or at least 3 of 4 MLN9708 doses in Arm D and had measurable disease at baseline and at least 1 post-baseline response assessment.","reportingStatus":"POSTED","timeFrame":"Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}