Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
I. To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH
(idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic
transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post
autologous transplant myeloma patients.
II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of
endogenous idiotype specific immune response.
III. To characterize the time course, specificity and persistence of antibody and T cell
immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.
IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor
myeloma involvement in bone marrow and serum paraprotein level following vaccination.
VI. Use stored patient samples to clone, expand, and characterize T cells specific for
myeloma antigens other than idiotype and identify the antigens they recognize so that they
can be used in future studies.
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with
sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily
(QD) for three days following each vaccine injection. Some patients also receive aldesleukin
SC daily from weeks 2-14.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria
Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
Up to 2 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|