Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/13/2018 |
Start Date: | October 2010 |
End Date: | January 2018 |
Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
The purpose of this study is to better understand what effects Bortezomib, a drug used for
multiple myeloma therapy, has on the immune system.
multiple myeloma therapy, has on the immune system.
Subjects on this study will be receiving treatment for multiple myeloma according to the
standard of care with a regimen containing Bortezomib.
If a bone marrow sample is clinically indicated to guide treatment, an additional 1
tablespoon of the specimen will be obtained for further laboratory studies.
Approximately 3 tablespoons of blood will be taken for research purposes before therapy with
Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional
3 tablespoons of blood will be taken for research purposes.
Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3
and 6 months after completing therapy.
This study also includes a medical record review.
standard of care with a regimen containing Bortezomib.
If a bone marrow sample is clinically indicated to guide treatment, an additional 1
tablespoon of the specimen will be obtained for further laboratory studies.
Approximately 3 tablespoons of blood will be taken for research purposes before therapy with
Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional
3 tablespoons of blood will be taken for research purposes.
Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3
and 6 months after completing therapy.
This study also includes a medical record review.
Inclusion Criteria:
- Newly diagnosed multiple myeloma
- Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the
standard of care therapy for myeloma by their treating physician
Exclusion Criteria:
- Hypersensitivity to bortezomib, boron or mannitol
- Treatment with other investigational drugs within 28 days before enrollment
- Diagnosed or treated for another malignancy within 6 months of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
- Use of other myeloma directed therapy (except for dexamethasone) in combination with
bortezomib
We found this trial at
2
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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