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Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00116441
First received: June 29, 2005
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

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

Keywords provided by Cell Genesys:
Multiple Myeloma
Cancer
PSCT
 Peripheral Stem Cell Transplant
Chemotherapy
GVAX

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013