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

Tracking Information
First Received Date ^ICMJE	June 29, 2005
Last Updated Date	December 18, 2007
Start Date ^ICMJE	October 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2005)	Multiple myeloma
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00116441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Biological: Therapeutic Cellular Vaccine, GM-CSF Producing
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date	October 2004
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00116441
Other Study ID Numbers ^ICMJE	K-0007, K-0007
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Cell Genesys
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cell Genesys
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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