UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
This is an experimental treatment that will consist of receiving special white blood cell
administrations either underneath the skin or in the lymph nodes. In this protocol,
treatment will be given according to the "risk group". If there are certain abnormalities
in the chromosomes, the disease is considered to be high risk. High-risk patients will
first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white
blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white
blood cells are saved, and the remaining blood is given back to you. These dendritic cells
will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet
hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma
antigens. It is hoped that this will cause these cells to interact with and activate T
cells, which will then destroy myeloma cells in your body. Half of these white cells will be
injected into your lymph nodes (intranodally) and half will be given subcutaneously. High
risk patients will receive a chemotherapy regimen called DT PACE.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Van Rhee Frits, M.D.
United States: Institutional Review Board
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