Refractory Multiple Myeloma Clinical Trial
Official title:
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
The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful
PRIMARY OBJECTIVES:
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.
OUTLINE:
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.
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