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

Trial ID or NCT#

NCT00186316

Status

not recruiting iconNOT RECRUITING

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 17 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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
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Investigator(s)

Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Judith Shizuru
Judith Shizuru
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

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Contact

BMT Referrals
6507230822

View on ClinicalTrials.gov