{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.31","upperLimit":"38.67","value":"18.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"Progression Free Survival is defined as time in months from start of study treatment to first documentation of objective tumor progression per investigator assessment or up to death due to any cause, whichever occurs first. Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be \\>10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.","dispersionType":"95% Confidence Interval","groups":[{"description":"Ixazomib 4.0 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 to 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":"OG000","title":"Arm B: Ixazomib 4.0 mg (RP2D)"}],"paramType":"MEDIAN","populationDescription":"The safety population consisted of participants who received at least 1 dose of any study drug.","reportingStatus":"POSTED","timeFrame":"From the date of enrollment to the date of the first documented disease progression or death due to any cause for up to 5.5 years","title":"Progression Free Survival (Phase 2)","type":"SECONDARY","unitOfMeasure":"months"}