{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"13.1","value":"2.6"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"5.4","value":"1.5"},{"groupId":"OG002","lowerLimit":"0.1","upperLimit":"6.2","value":"1.4"},{"groupId":"OG003","lowerLimit":"0.0","upperLimit":"26.5","value":"3.6"},{"groupId":"OG004","lowerLimit":"0.5","upperLimit":"2.3","value":"1.1"},{"groupId":"OG005","lowerLimit":"0.7","upperLimit":"1.4","value":"1.4"},{"groupId":"OG006","lowerLimit":"0.0","upperLimit":"40.4","value":"8.0"},{"groupId":"OG007","lowerLimit":"0.0","upperLimit":"22.7","value":"3.4"},{"groupId":"OG008","lowerLimit":"0.03","upperLimit":"15.44","value":"4.1"},{"groupId":"OG009","lowerLimit":"0.03","upperLimit":"19.81","value":"5.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"18"},{"groupId":"OG007","value":"13"},{"groupId":"OG008","value":"43"},{"groupId":"OG009","value":"44"}],"units":"Participants"}],"description":"PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase \\>10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.","dispersionType":"Full Range","groups":[{"description":"Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG000","title":"Part 1 (Dose Escalation) Schedule A"},{"description":"Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","id":"OG001","title":"Part 1 (Dose Escalation) Schedule B"},{"description":"Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG002","title":"Part 1 (Dose Escalation) Schedule C"},{"description":"Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG003","title":"Part 1 (Dose Escalation) Schedule D"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG004","title":"Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","id":"OG005","title":"Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG006","title":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","id":"OG007","title":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone"},{"description":"Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","id":"OG008","title":"Part 3 (Dose Extension): Modakafusp Alfa 120 mg"},{"description":"Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","id":"OG009","title":"Part 3 (Dose Extension): Modakafusp Alfa 240 mg"}],"paramType":"MEDIAN","populationDescription":"The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analysis.","reportingStatus":"POSTED","timeFrame":"Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3","title":"Parts 1, 2, and 3: Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}