UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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.
Inclusion Criteria:
- Patients must have confirmed diagnosis of one of the following: Smoldering or
indolent multiple myeloma, Multiple myeloma more than 1 year after autologous
transplant and with stable disease, or Multiple myeloma with cytogenetic
abnormalities
- Patients with secretory IgA or IgG must have purified idiotype protein available
and/or tumor cells available, and patients with light chain or non-secretory myeloma
must have tumor cells available
- Karnofsky performance score greater than or equal to 60
- ANC greater than or equal to 1,000/microliters, platelet count greater than or equal
to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
- Expected survival of 3 months or more
- 18 years of age and older
- Have given a written consent and been informed about the investigational nature of
the study.
- Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen
Exclusion Criteria:
- Patients with CD4 count < 400/microliters, and/or with severely damaged immune
functions
- Chemotherapy or other immunosuppressive treatment with steroids, cytoxan,
methotrexate within 8 weeks
- Fever or active infection
- Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater
than or equal to 3 x ULN
- Renal function: Patients on dialysis
- Simultaneous treatment with a second investigational drug or biologic agent
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
Van Rhee Frits, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UAMS
Authority:
United States: Institutional Review Board
Study ID:
UARK 2000-46
NCT ID:
NCT00083538
Start Date:
February 2001
Completion Date:
December 2007
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- DTPACE
- Dexamethasone
- Thalidomide
- Cisplatin
- Cytoxan
- Doxorubicin
- Etoposide
- Dendritic Cell Vaccination
- Leukapheresis
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| University of Arkansas for Medical Sciences/MIRT | Little Rock, Arkansas 72205 |
