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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Stanford University
National Cancer Institute (NCI)
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00186316
  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.


Condition Intervention Phase
Multiple Myeloma
Biological: Idiotype-pulsed allogeneic dendritic cells
Phase I
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:   A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Patient will complete 4 vaccinations of monthly interval

Secondary Outcome Measures:
  • 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.

Estimated Enrollment:   30
Study Start Date:   April 2003

Detailed Description:

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

  Eligibility
Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
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
  • Clincally 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 blilirubin < 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 (allodonor is the same donor used for non-myeloablative transplant)

  • Age >17 years
  • HIV negative
  • Must provide signed, informed consent Exclusion Criteria:Patient 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:

    i. Mycophenylate Mofetil (MMF)- no greater than 1000mg twice a day ii. Prednisone- no greater than .5mg/kg/day iii. Cyclosporine- no greater than 300mg/day iv. Tacrolimis (FK506)- no greater than 4mg/day

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186316

Locations
United States, California
Stanford University School of Medicine    
      Stanford, California, United States, 94305

Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Ronald Levy     Stanford University    
  More Information

Study ID Numbers:   BMT155, BMT155, NCT00186316
First Received:   September 13, 2005
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00186316
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 04, 2008




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