Expired Study
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Stanford, California 94305


Purpose:

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.


Study summary:

To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.


Criteria:

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: 1. Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day 2. Prednisone- no greater than .5mg/kg/day 3. Cyclosporine- no greater than 300mg/day 4. Tacrolimus (FK506)- no greater than 4mg/day


NCT ID:

NCT00186316


Primary Contact:

Principal Investigator
Ronald Levy
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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