Status:
COMPLETED
The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer ...
Detailed Description
* To create the study vaccine, cells will be removed from the participants tumor and fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained from the participants blood....
Eligibility Criteria
Inclusion
- Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
- Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with a greater than nine week life expectancy
- \> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
- Laboratory results within ranges outlined in protocol
- Negative pregnancy test and adequate contraception method(s) must be documented
Exclusion
- History of clinically significant venous thromboembolism
- Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
- Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
- Clinically significant autoimmune disease
- HIV positive
- Serious intercurrent illness
- Taking systemic corticosteroids within 4 weeks of treatment with study drug
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00459069
Start Date
July 1 2004
End Date
November 1 2009
Last Update
January 12 2010
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02114