{"analyses":[{"ciLowerLimit":"51.2","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"78.4","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"p-value is calculated using Fisher's exact test and is a one-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.","paramType":"Proportion of Patients Achieving CR/sCR","paramValue":"65.8","statisticalComment":"One-sided test with a 5% significance level that tests whether the proportion of successes is greater than 10%.","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}],"title":"Acheived CR/sCR by 6 Months post Infusion"},{"measurements":[{"groupId":"OG000","value":"13"}],"title":"Did Not Acheive CR/sCR by 6 Months post Infusion"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"}],"units":"Participants"}],"description":"Achieving a complete response or better (CR or sCR) as assessed by the 6-month time point after BCMA CAR T-cell therapy in MM patients with suboptimal disease responses after an autologous HCT and lenalidomide maintenance.","groups":[{"description":"Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\\^2 and fludarabine 30mg/m\\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression.\n\nLenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression\n\nbb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\\^6 cells.\n\nCyclophosphamide: 300 mg/m\\^2/day for 3 consecutive days prior to the CAR T infusion\n\nFludarabine: 30 mg/m\\^2/day or 3 consecutive days prior to the CAR T infusion\n\nleukapheresis: Placement of central line catheter and leukapheresis","id":"OG000","title":"Lenalidomide and bb2121"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who received BCMA CAR T-Cell Therapy","reportingStatus":"POSTED","timeFrame":"6 months","title":"Efficacy of BCMA CAR-T Cell Therapy","type":"PRIMARY","unitOfMeasure":"Participants"}