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

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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.

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.

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
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sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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