Evaluating the Interest of GEP-based Derived Histone Acetylation Score to Identify Myeloma Patients Who Could Benefit From Treatment With HDAC Inhibitor
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
研究概览
简要总结
Panobinostat is a potent oral histone deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the US Food and Drug Administration for use in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma (MM) who have received ≥ 2 prior regimens, including bortezomib and an immunomodulatory drug.
A GEP-based histone acetylation score allowing identification of MM patients with a poor prognosis and who could benefit from HDACi treatment was recently reported(Moreaux et al. BJC. 2013).
Our hypothesis is that the histone acetylation score could be promising to identify MM patients who could benefit from treatment with HDACi and the development of personalized treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Relapsed/refractory multiple myeloma
- •Aged 18 years or more with no upper age limit
- •Have signed an informed consent
排除标准
- 未提供
结局指标
主要结局
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
时间窗: 1 day
Overall Response Response rate 'ORR', PR and better (as per IMWG criteria) of MM patients after treatment with Panobinostat according to histone acetylation score value
次要结局
- Progression free survival will be monitored.(1 day)