{"denoms":[{"counts":[{"groupId":"BG000","value":"50"}],"units":"Participants"}],"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":"BG000","title":"Induction"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"37","upperLimit":"70","value":"59"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"27"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"44"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28"}]}],"title":"I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}],"title":"III"}],"description":"The International Staging System (ISS) for multiple myeloma predicts the severity of multiple myeloma based on routinely obtained lab values (serum beta-2 microglobulin and serum albumin), with severity increasing from Stage I to Stage III.\n\nStage I: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin greater than or equal to 3.5 g/dL.\n\nStage II: serum beta-2 microglobulin less than 3.5 mg/L and serum albumin less than 3.5 g/dL, OR beta-2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin.\n\nStage III: serum beta-2 microglobulin greater than 5.5 mg/L","paramType":"COUNT_OF_PARTICIPANTS","title":"ISS Stage at Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}]}],"title":"I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"32"}]}],"title":"II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"title":"III"}],"description":"The Revised International Staging System (R-ISS) predicts the severity of myeloma, with severity increasing from Stage I to III.\n\nI: serum beta-2 microglobulin less than 3.5 mg/L, serum albumin greater than or equal to 3.5 g/dL, no high-risk chromosomal abnormalities (CA)\\* by fluorescence in-situ hybridization (FISH), normal lactate dehydrogenase (LDH)\n\nII: does not meet criteria for R-ISS Stage I or III.\n\nIII: serum beta-2 microglobulin greater than or equal to than 5.5 mg/L AND high-risk CA\\* by FISH OR high LDH\n\n\\*High risk CAs: del(17p), translocation t(4;14), translocation t(14;16)","paramType":"COUNT_OF_PARTICIPANTS","title":"Revised ISS Stage at Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28"}]}],"title":"0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"22"}]}],"title":"1"}],"description":"ECOG performance status describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability.\n\nGrade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"23"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"BG000","value":"23"}]}],"title":"No"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"title":"Unknown"}],"description":"High risk cytogenetics defined as deletion 17p, gain of 1q, and translocations t(4:14), t(14;16), and/or t(14;20).","paramType":"COUNT_OF_PARTICIPANTS","title":"High Risk Cytogenetics","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}],"title":"IgG"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"title":"IgA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}],"title":"Light-chain only"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Unknown"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Serum Heavy Light Chain","unitOfMeasure":"Participants"}]}