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

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

This study is ongoing, but not recruiting participants.

Study NCT00186316. Last updated on October 23, 2008. Information provided by Stanford University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

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

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Primary Outcome Measure ^†

Patient will complete 4 vaccinations of monthly interval

Secondary 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.

Condition ^†

Multiple Myeloma

Intervention ^†

Biological: Idiotype-pulsed allogeneic dendritic cells

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

April 2003

Completion Date

Eligibility 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 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: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. Mycophenylate 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. Tacrolimis (FK506)- no greater than 4mg/day

Gender

Both

Ages

17 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00186316

Organization ID

BMT155

Secondary IDs ^††

79000, BMT155, NCT00186316

Study Sponsor ^†

Stanford University

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Ronald Levy

Stanford University

Information Provided By

Stanford University

Verification Date

October 2008

First Received Date ^†

September 13, 2005

Last Updated Date

October 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.