{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"}],"units":"Participants"}],"description":"Percentage of patients who achieved a complete response (CR) or stringent CR (sCR) per International Myeloma Working Group (IMWG) Uniform Response criteria after 4 cycles of of Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (KRDI). IMWG criteria define a CR as \"Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow\" and an sCR as \"CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.\"","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","title":"Complete Response (CR + Stringent CR) Rate","type":"PRIMARY","unitOfMeasure":"Participants"}