Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Effect of bortezomib on circulating dendritic cell and T cell populations
研究概览
简要总结
The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effect of bortezomib on circulating dendritic cell and T cell populations
时间窗: 2 years
Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy
次要结局
未报告次要终点
研究者
Jacalyn Rosenblatt, MD
Principal Investigator
Beth Israel Deaconess Medical Center