Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
This trial is active, not recruiting.
|Sponsor||Beth Israel Deaconess Medical Center|
|Start date||October 2010|
|End date||October 2016|
|Trial size||20 participants|
|Trial identifier||NCT01472627, 10-272|
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 receiving standard of care regimen including Bortezomib
Effect of bortezomib on circulating dendritic cell and T cell populations
time frame: 2 years
Male or female participants at least 18 years old.
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
|Official title||Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro|
|Principal investigator||Jacalyn Rosenblatt, MD|
|Description||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.|
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