{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"}],"units":"Participants"}],"description":"Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycle 8.\n\nThe flow cytometry analysis procedure used to determine MRD is performed on a NAVIOS FLOW CYTOMETER SYSTEM manufactured by BECKMAN COULTER, INC., using a laboratory developed assay.\n\nThe Premarket Notification 510(k) (Number K130373) for the device can be found using the following link.\n\nhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130373.","groups":[{"description":"Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression.\n\nElotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15\n\nCarfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond\n\nLenalidomide: Lenalidomide will be given on days 1-21 for all cycles.\n\nDexamethasone: Dexamethasone will be given as follows:\n\nCycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22","id":"OG000","title":"Elo-KRd Regimen"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One censored because of autologous stem cell transplant cycle 8 without progression","reportingStatus":"POSTED","timeFrame":"Landmark evaluations were performed after cycle 8","title":"Number of Participants With MRD-negativity (10^-5) After C8 Elo-KRd","type":"PRIMARY","unitOfMeasure":"Participants"}