{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"16"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"16"}],"units":"Participants"}],"description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG000","title":"0.3 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG001","title":"1 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG002","title":"3 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG003","title":"9 x 10^6 CAR-BCMA T-cells Infused"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells.","title":"Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)","type":"PRIMARY","unitOfMeasure":"Participants"}