Neurofilament Light Chain as Biomarker for Bortezomib-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Level of plasma neurofilament light chain
研究概览
简要总结
Investigation of which patients treated with bortezomib that have increased risk of developing peripheral neuropathy.
详细描述
The study aims to include 20 patients with multiple myeloma that are initiating bortezomib treatment. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 9 cycles.
Blood is dawn before treatment initiation and approximately once per cycle in order to measure neurofilament light chain (NFL) before and during treatment. The primary outcome is to relate the level of NFL during treatment with the level at baseline and as a secondary outcome to relate the level of NFL to the cumulative dose of bortezomib.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Above 18 years of age
- •Must speak and understand Danish
- •Must be able to and willing to give informed consent
- •Diagnosed with myeloma and in need for treatment
- •Must not be a candidate for transplantation and must be a candidate for bortezomib treatment.
- •Must not previously have been treated with proteasome inhibitors
- •Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 3
排除标准
- •Other underlying cancer disease - with exception of a) basal cell carcinoma, b) healed carcinoma in situ cervicis uteri, c) other cancer disease with minimal risk of recurrence or d) prostate cancer with low glean score
- •Previous treatment with neurotoxic chemotherapy
- •Known polyneuropathy or at diagnosis have polyneuropathy degree 1 with pain or degree 2 without pain.
- •Simultaneous amyloidosis/POEMS syndrome
- •Patients who have received chemotherapy previously and patients with diabetes, HIV and neurodegenerative diseases.
结局指标
主要结局
Level of plasma neurofilament light chain
时间窗: Day 1 in cycle 9 (each cycle is often between 3-6 weeks)
Plasma neurofilament light chain during treatment with bortezomib. (Cycle length can vary).
次要结局
- Level of plasma neurofilament relative to cumulative dose of bortezomib(From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.)
- Degree of peripheral neuropathy(From cycle 1 (each cycle is often between 3-6 weeks) and forward, maximum 9 cycles in total. An average of 1 year.)