Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Study of Xcellerated T Cells After Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Patients will have immune cells collected and then expanded outside of the body. Patients will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem cell transplantation. Three days following the transplant, patients will receive an infusion of a large number of expanded immune cells. The goal of the study will be to determine the safety as well as potential efficacy of this treatment.
This Phase I/II clinical study is designed to examine the safety of Xcellerated T Cells, an
activated, autologous T cell product, in study subjects undergoing an autologous peripheral
blood stem cell transplant for the treatment of multiple myeloma. Thirty-five patients will
be treated. Patients must have undergone induction therapy prior to study registration, and
may not have progressed following induction therapy or any other prior therapy for myeloma.
Patients will undergo a steady state leukapheresis (Xcellerate Leukapheresis) to obtain
peripheral blood mononuclear cells that will be used to produce Xcellerated T Cells. During
the Xcellerate Process, T cells will be activated and expanded ex vivo by co-stimulation
with anti-CD3 and anti-CD28 monoclonal antibodies covalently attached to super-paramagnetic
microbeads. While the Xcellerated T Cells are being produced at Xcyte Therapies, patients
will be treated with a standard mobilization regimen consisting of cyclophosphamide and
filgrastim (Neupogen; G-CSF), followed by a second leukapheresis for collection of
peripheral blood stem cells. Patients will be treated with a standard high-dose chemotherapy
regimen for multiple myeloma consisting of single agent melphalan (200mg/m2). Patients will
then receive their peripheral blood stem cells followed by post-transplant filgrastim for
neutrophil recovery. Three days (Day 3) following stem cell infusion, patients will receive
a single dose Xcellerated T Cells.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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