{"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}],"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":"BG000","title":"Lenalidomide and bb2121"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"7.72","value":"61.2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"38"}],"units":"Participants"}]}],"description":"Age at Infusion (years)","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"This row is only for infused patients and therefore has less participants in this row than others as not all enrolled participants were infused.","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"29"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"34"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"2"}],"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":"29"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}],"title":"70 or 80"},{"measurements":[{"groupId":"BG000","value":"23"}],"title":"90 or 100"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"KPS describes patient-perceived global quality of life and functioning on a scale of 0-100.\n\n100: No evidence of disease; 90: Normal activity. Minor signs or symptoms of disease; 80: Normal activity with effort. Some signs or symptoms of disease; 70: Cares for self. Unable to continue normal activity; 60: Needs occasional assistance, but cares for most personal needs; 50: Needs considerable assistance and medical care; 40: Disabled. Needs special care and assistance; 30: Severely disabled. Hospital admission indicated; 20: Very sick. Active supportive therapy needed; 10: Moribund; 0: Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"Karnofsky Performance Score","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"IgA Kappa"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"IgA Lambda"},{"measurements":[{"groupId":"BG000","value":"20"}],"title":"IgG Kappa"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"IgG Lamda"},{"measurements":[{"groupId":"BG000","value":"8"}],"title":"Kappa light chain"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Lambda light chain"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"There are 5 types of heavy chains: IgG, IgA, IgD, IgE, and IgM. There are 2 types of light chains: kappa and lambda Immunoglobulins are made up of a heavy chain and a light chain. The diagnosis of myeloma is labelled according to the type of immunoglobulin that has become abnormal.","paramType":"COUNT_OF_PARTICIPANTS","title":"Multiple Myeloma Paraprotein Type","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14"}],"title":"I"},{"measurements":[{"groupId":"BG000","value":"18"}],"title":"II"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"III"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Stage I: Serum B2 microglobulin \\< 3.5mg/L; serum albumin \\>= 3.5 g/dL Stage II: Serum B2 microglobulin \\< 3.5mg/L; serum albumin \\< 3.5 g/dL; OR Serum B2 microglobulin 3.5 to 5.5 mg/L, irrespective of serum albumin Stage III: Serum B2 microglobulin \\> 5.5. mg/L","paramType":"COUNT_OF_PARTICIPANTS","title":"ISS Stage at Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"}],"title":"I"},{"measurements":[{"groupId":"BG000","value":"20"}],"title":"II"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"III"},{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Stage I: Serum B2 microglobulin \\< 3.5 mg/L; Serum albumin \\>= 3.5 g/dL; Standard-risk chromosomal abnormalities (CA) by iFISH; normal lactate dehydrogenase levels (LDH) Stage II: Nor R-ISS Stage I or III Stage III: Serum B2 microglobulin \\>= 5.5 mg/L and either high risk CA by iFISH or high LDH","paramType":"COUNT_OF_PARTICIPANTS","title":"R-ISS Stage at Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"}],"title":"High risk"},{"measurements":[{"groupId":"BG000","value":"7"}],"title":"No abnormalities"},{"measurements":[{"groupId":"BG000","value":"23"}],"title":"Standard risk"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Cytogenetic abnormalities can assess the risk and prognosis of multiple myeloma. High risk includes t(4;14), t(14;16), t(14;20), del17p, 1q amplification, and \\>=2 HRCA. Standard risk includes chromosomal hyperdiploid. High risk indicates worse outcomes.","paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetics","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"}],"title":"High risk"},{"measurements":[{"groupId":"BG000","value":"28"}],"title":"Standard risk"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"myeloma risk defines high risk disease based on ISS 3 and or high risk cytogenetics (t(4;14), t(14;16), t(14;20), deletion 17p or p53 deletion or amplification of 1q). Others are included in standard risk. High risk indicates worse outcomes.","paramType":"COUNT_OF_PARTICIPANTS","title":"Myeloma Risk Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32"}],"title":"1 Line"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"2 Lines"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"3 Lines"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Lines of Initial Systemic Anti-Myeloma Therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}],"title":"VGPR"},{"measurements":[{"groupId":"BG000","value":"30"}],"title":"PR"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"SD"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"PR: \\>=50% reduction (RED) in serum monoclonal paraprotein (PP) \\& RED in 24hr urinary monoclonal PP by \\>=90% or to \\<200 mg/24hr; or if M protein unmeasurable: \\>=50% RED in difference b/w involved \\& uninvolved FLC levels or 50% RED of involved FLC w/ 50% RED in ratio; or only bone marrow (BM) measurable: \\>=50% RED in BM plasma cells if baseline \\>=30%; or \\>=50% RED in size of soft tissue plasmacytomas. VGPR: PR \\& Serum or urine PP detectable by immunofixation but not electrophoresis; OR \\>=90% serum PP RED + urine PP \\<100 mg/24hr \\& \\>90% involved light chain RED. SD: none of above \\& no progression.","paramType":"COUNT_OF_PARTICIPANTS","title":"Disease Status Prior to Transplant","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22"}],"title":"VGPR"},{"measurements":[{"groupId":"BG000","value":"17"}],"title":"PR"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"MR"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"MR: \\>=25% \\& \\<50% RED in serum monoclonal PP and RED in 24hr urinary monoclonal protein by 50-89%; or \\>=50% RED in size of soft tissue plasmacytomas if present at baseline.","paramType":"COUNT_OF_PARTICIPANTS","title":"Disease Status Prior to Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22"}],"title":"VGPR"},{"measurements":[{"groupId":"BG000","value":"13"}],"title":"PR"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"MR"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Missing"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"No LD Chemotherapy"}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Disease Status at LD Chemotherapy Initiation","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"2.34","value":"7.1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Interval is calculated as (Date of transplant - date of diagnosis of symptomatic multiple myeloma +1)/(365.25/12)","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Interval from Diagnosis of Symptomatic Multiple Myeloma to Transplant","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"2.77","value":"16.2"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Interval is calculated as (Date of enrollment - date of diagnosis of symptomatic multiple myeloma +1)/(365.25/12)","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"interval from diagnosis of symptomatic Multiple Myeloma to enrollment","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"1.68","value":"9.1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}]}],"description":"Interval is calculated as (Date of enrollment - date of transplant +1)/(365.25/12)","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Interval from Transplant to Enrollment","unitOfMeasure":"months"}],"populationDescription":"Enrolled Participants"}