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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

August 21, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patient will complete 4 vaccinations of monthly interval

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00186316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Biological: Idiotype-pulsed allogeneic dendritic cells

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

17 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00186316

Responsible Party

Ronald Levy, Principal Investigator, Stanford University School of Medicine

Study ID Numbers ^ICMJE

BMT155, 79000, BMT155, NCT00186316

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Ronald Levy

Stanford University

Information Provided By

Stanford University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP