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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186316
First received: September 13, 2005
Last updated: August 21, 2009
Last verified: August 2009
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Resource links provided by NLM:


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
Study Completion Date: December 2008
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Ronald Levy Stanford University
  More Information

No publications provided

Responsible Party: Ronald Levy, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186316     History of Changes
Other Study ID Numbers: BMT155, 79000, BMT155
Study First Received: September 13, 2005
Last Updated: August 21, 2009
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014