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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00186316
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 25, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Idiotype-pulsed allogeneic dendritic cells Phase 1 Phase 2

Detailed Description:
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Study Start Date : April 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Patient will complete 4 vaccinations of monthly interval

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186316


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ronald Levy Stanford University
More Information
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Responsible Party: Ronald Levy, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186316    
Other Study ID Numbers: BMT155
79000
BMT155
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs