Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Study Overview
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Brief Summary
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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.

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

Official Title
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A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: Idiotype-pulsed allogeneic dendritic cells


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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Idiotype-pulsed allogeneic dendritic cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient will complete 4 vaccinations of monthly interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of immune response. Immune response analysis will be done on all patients who are enrolled in the study. Patients who completed a minimum of 4 vaccinations will be included in immune response. |  |  |