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Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00116441
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : December 24, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Biological: Therapeutic Cellular Vaccine, GM-CSF Producing Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2000
Estimated Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Multiple myeloma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116441


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Cell Genesys
More Information

ClinicalTrials.gov Identifier: NCT00116441     History of Changes
Other Study ID Numbers: K-0007
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

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