25
Participants
Start Date
May 13, 2011
Primary Completion Date
August 25, 2017
Study Completion Date
July 8, 2019
Autologous Genetically modified T cells
"Patients will undergo myeloma restaging at days +42, +100, 6 months, 9 months and 1 year post infusion. At this point, in accordance with FDA Guidelines, all patients will enter long term follow up (LTFU) and be followed biannually for monitoring for gene transfer delayed adverse events until year 5 post infusion. From year 5, all patients will require annual LTFU visits for monitoring for delayed adverse events until year 15 after receiving the genetically modified T cells.~Patients whose disease progresses prior to year 1 will enter LTFU at time of progression; however these patients will be seen quarterly from progression until year 1 post infusion and then follow the LTFU schedule mentioned above."
GSK Investigational Site, Philadelphia
GSK Investigational Site, Baltimore
Lead Sponsor
GlaxoSmithKline
INDUSTRY