Safety and Immune Response Evaluation of Autologous Myeloma Idiotype-KLH/GM-CSF Vaccination in Post Transplant Myeloma Patients
autologous immunoglobulin idiotype-KLH conjugate vaccine
+ sargramostim
+ aldesleukin
Blood Protein Disorders+12
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: March 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.22 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: ELIGIBILITY FOR VACCINE PREPARATION: Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION: Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera Greater than 60 days post BMT Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse Stable absolute neutrophil count (ANC) > 1000 Platelet count > 50,000 not requiring transfusions or growth factors Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week Treatment with a stable dose of Interferon is allowed Karnofsky status > 60 percent Immunosuppression: Off all corticosteroids Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only Exclusion Criteria: Graft-vs-host disease requiring treatment with corticosteroids Serum creatinine > 3.0 Uncontrolled infection Disease progression Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol Patients with a history of serious adverse reactions to GM-CSF Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, United StatesOpen Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium in Google Maps