Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

This study has been completed.

First Received: June 29, 2005 Last Updated: December 18, 2007 History of Changes

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00116441

Purpose

The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.

Condition	Intervention	Phase
Multiple Myeloma	Biological: Therapeutic Cellular Vaccine, GM-CSF Producing	Phase I Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line

Further study details as provided by Cell Genesys:

Primary Outcome Measures:

Multiple myeloma

Estimated Enrollment:	22
Study Start Date:	October 2000
Estimated Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

De novo multiple myeloma
ECOG 0-2
No serious co-morbid illnesses and adequate organ function
> 4 weeks from systemic steroids

Exclusion Criteria:

No existing secondary malignancies and no history of secondary malignancies in the past 5 years
No active autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116441

Locations

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231

Sponsors and Collaborators

Cell Genesys

More Information

No publications provided

Study ID Numbers:	K-0007, K-0007
Study First Received:	June 29, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00116441 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

Multiple Myeloma
Cancer
PSCT

Peripheral Stem Cell Transplant
Chemotherapy
GVAX

Study placed in the following topic categories:

Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases

Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

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

ClinicalTrials.gov processed this record on May 07, 2009