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

Sponsor:	Stanford University
Collaborator:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

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

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

No publications provided

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

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immunoglobulin Idiotypes
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 22, 2009