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临床试验/NCT03210753
NCT03210753Unknown不适用

Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple Myeloma

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
peripheral neuropathy

研究概览

简要总结

Background and objective

The introduction of a proteasome inhibitor bortezomib has significantly improved response rates and overall survival in patients with multiple myeloma (MM), and it has soon become the cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However, the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which becomes an obstacle during treatment with bortezomib, either alone or in combination. Until now, there are no consistent findings regarding the risk factors that may cause BiPN. There is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk factors of BiPN using retrospective analysis in a large cohort with longer observation period as well as the relations between BiPN and gene polymorphisms, and to compare different routes in the incidence of BiPN.

Methods

This is a retrospective cohort study with a sample size of about 400 MM patients treated ever with at least one full cycle of bortezomib in the institution. All the patients enrolled need to be adults (≧20 years ) with measurable M-component in either blood or urine. The investigators will perform a retrospective chart review to collect clinical data, including anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also plan to perform genotyping for the possible genetic factors associated with development of BiPN.

Expected contributions

The successful collaboration between clinical hematologist-oncologist and biopharmaceutical researcher would result in the concrete evidence of efficacy and safety of bortezomib in Taiwanese patients with MM. The findings in this large cohort study will unveil the risk factors of BiPN, including the administration routes and ethnicity. As results, the investigators would be able to provide the precision medicine-based bortezomib treatment strategy to MM patients in Taiwan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

peripheral neuropathy

时间窗: 2006/4/1-2016/12/31

identified the record of peripheral neuropathy, neuropathy, numbness, tingling, weakness symptoms by chart review

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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