{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"5"}],"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":"1x10(5) Th1/Tc1.Rapa cells/kg of body weight","id":"OG000","title":"Cohort 1 - 1x10(5) T Cells/kg"},{"description":"5x10(5) Th1/Tc1.Rapa cells/kg of body weight","id":"OG001","title":"Cohort 2 - 5x10(5) T Cells/kg"},{"description":"1x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG002","title":"Cohort 3 - 1x10(6) T Cells/kg"},{"description":"3x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG003","title":"Cohort 4 - 3x10(6) T Cells/kg"},{"description":"5x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG004","title":"Cohort 5 - 5x10(6) T Cells/kg"},{"description":"5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.","id":"OG005","title":"Cohort 5B - 5x10(6) T Cells/kg"},{"description":"15x10(6) Th1/Tc1.Rapa cells/kg of body weight","id":"OG006","title":"Cohort 6 - 15x10(6) T Cells/kg"},{"description":"45x10(6) th1 cells/kg of body weight","id":"OG007","title":"Cohort 7 - 45x10(6) T Cells/kg"},{"description":"Th1/Tc1.Rapa Prevention of Relapse\n\nAdoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).\n\nRapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.\n\nTh1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg","id":"OG008","title":"Cohort A - Th1/Tc1.Rapa Prevention of Relapse"},{"description":"Th1/Tc1.Rapa for Relapsed Multiple Myeloma\n\nAdoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).\n\nTh1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg","id":"OG009","title":"Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to last date off study, 81 months and 6 days","title":"Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)","type":"SECONDARY","unitOfMeasure":"Participants"}