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

August 21, 2009 updated by: Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient will complete 4 vaccinations of monthly interval

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 21, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT155
  • 79000
  • NCT00186316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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