A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell transplant will receive 6 vaccinations of donor derived dendritic cells combined with specific protein produced by multiple myeloma.
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
Inclusion Criteria:1. For specimen collection and idiotype protein development:
Must be secretory myeloma with at least .5g/dl serum IgG protein
Clinically stage 2 or 3 multiple myeloma
Karnofsky performance status of 70 or greater
2. For Vaccination:
Eligible patients must have completed tandem autologous and nonmyeloablative allogeneic transplant for multiple myeloma at Stanford University Medical Center with stable disease or complete response to prevaccine therapy
Karnofsky performance status of 70 or greater.
ALT and AST must be <2X upper limit of normal. Total bilirubin < 1.5X upper limit of normal.
Serum creatinine <1.5X upper limit of normal.
Hemoglobin >9g/dl
Patients must be HIV negative.
Patients must provide signed, informed consent
Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant)
Age >17 years
HIV negative
Must provide signed, informed consent Exclusion Criteria:1. For specimen collection and idiotype protein development:
Patients with non-secretory myeloma
Severe psychological or medical illness
Pregnant or lactating women
Subjects with > Grade I toxicity by NCI-CTC v 3.0
Subjects with prognosis < 6 months
2. For Vaccination:
< 75 mg of idiotype protein purified from the patients serum
< 25 million allogeneic idiotype-pulsed dendritic cells produced for vaccination
Evidence of grade II-IV acute GVHD (defined in section 5E)
Patients with evidence of myeloma disease progression as (defined below)
Severe psychological or medical illness or concomitant medications which may interfere with the study as determined by the clinical investigator
Patients on any other investigational agents
Pregnant or lactating women
Patients on any therapy for multiple myeloma or any chemotherapy drug, or immunomodulatory agent for treatment of multiple myeloma (e.g. thalidomide)
Any patient on more than two of the following immunosuppressive agents or at a dose greater than that indicated for a single immunosuppressive agent: