Back to resultsVaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Therapeutic Cellular Vaccine, GM-CSF Producing
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Cancer, PSCT, Peripheral Stem Cell Transplant, Chemotherapy, GVAX
Eligibility 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
Sites / Locations
- Johns Hopkins University
Outcomes
Primary Outcome Measures
Multiple myeloma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116441
Brief Title
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cell Genesys
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Cancer, PSCT, Peripheral Stem Cell Transplant, Chemotherapy, GVAX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Therapeutic Cellular Vaccine, GM-CSF Producing
Primary Outcome Measure Information:
Title
Multiple myeloma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
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