Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma
NCT00458653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-06-22
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 patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.
Conditions
Interventions
- BIOLOGICAL
-
Dendritic Cell Tumor Fusion
Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses. Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER - collaborator OTHER
-
Brigham and Women's Hospital
collaborator OTHER -
Rambam Health Care Campus
collaborator OTHER -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
David Avigan, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-04-30
- Primary Completion
- 2012-04-30
- Completion
- 2020-07-31
Countries
- United States
- Israel
Study Locations
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