Redirected Auto T Cells for Advanced Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 13, 2011

Primary Completion Date

August 25, 2017

Study Completion Date

July 8, 2019

Conditions
Multiple Myeloma
Interventions
GENETIC

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."

Trial Locations (2)

19104

GSK Investigational Site, Philadelphia

21201

GSK Investigational Site, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01352286 - Redirected Auto T Cells for Advanced Myeloma | Biotech Hunter | Biotech Hunter