Status:
COMPLETED
Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for...
Detailed Description
* The first group of participants on this study will receive up to 3 monthly doses of the study vaccine beginning about 1 month following the autologous transplant. If this is found to be safe, the ne...
Eligibility Criteria
Inclusion
- Patients with multiple myeloma who are potential candidates for high dose chemotherapy
- Measurable disease as defined by a history of an elevated M component in plasma, urine, or free kappa/lambda light chains in the serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with greater than a nine week life expectancy
- Patients with \> 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
- Negative pregnancy test, and adequate contraception method
- DLCO (adjusted)\> 50%
- Cardiac Ejection Fraction \> 45%
- Laboratory values within the ranges outlined in the protocol
Exclusion
- History of clinically significant venous thromboembolism
- Clinically significant autoimmune disease
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Pregnant or lactating women
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00458653
Start Date
April 1 2005
End Date
July 1 2020
Last Update
June 22 2023
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute/Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
4
Rambam Medical Center
Haifa, Israel, 31096