{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"}],"units":"Participants"}],"description":"Overall response rate will be the percentage of patients who achieve at least partial response (PR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI).\n\nThe IMWG response criteria define a PR as:\n\n\\> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \\>90% or to \\< 200 mg/24 h, OR If the serum and urine M-protein are unmeasurable, a \\> 50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, OR If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \\> 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \\> 30%.\n\nIn addition to the above listed criteria, if present at baseline, a \\> 50% reduction in the size of soft tissue plasmacytomas is also required for a partial response.","groups":[{"description":"All participants will receive 4 cycles of induction therapy. Based on the recommendation of investigators, participants may or may not proceed to an autologous stem cell transplant (SCT) after cycles 1-4. Each cycle is 28 days in length (see dosing details below.)\n\nFor patient undergoing upfront stem cell transplant (SCT): 4 cycles followed by stem cell collection, high-dose chemotherapy, and autologous SCT followed by 2 cycles (called consolidation).\n\nFor patients deferring SCT following collection: 4 cycles followed by stem cell collection followed by 4 additional cycles.\n\nCarfilzomib: 56 mg/m2 IV on days 1, 8,15 Lenalidomide 25 mg orally (PO) on Days 1-21 Isatuximab: 10 mg/kg IV weekly for cycles 1-2 (days 1, 8, 15, 22), then every 2 weeks for cycles 3-6 (days 1 and 15), and monthly (day 1) thereafter Dexamethasone: 20 mg orally (PO) administered day of and day after carfilzomib and isatuximab (days 1, 2, 8, 9, 15, and 16; days 22 and 23 during cycles 1-2 only).\n\nPatients achieving a partial response (PR) or greater will be stratified by cytogenetic risk and receive either high risk (Lenalidomide 10 mg orally (PO) Day 1-21 Carfilzomib 56 mg/m2 or last tolerated dose IV Days 1, 15 Isatuximab 10 mg/kg IV Day 1) or low risk maintenance therapy (Lenalidomide 10 mg orally (PO) Day 1-21).","id":"OG000","title":"Induction"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"112 days (4 cycles)","title":"Overall Response Rate After 4 Cycles Induction Therapy","type":"SECONDARY","unitOfMeasure":"Participants"}