Correlation Between Serum Vitamin D Levels and the Incidence of Peripheral Neuropathy Among Multiple Myeloma Patients Who Have Previously Received Treatment With Bortezomib or Thalidomide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Serum vitamin D levels
研究概览
简要总结
This is a prospective study investigating the relationship between vitamin D and peripheral neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.
详细描述
Approximately 10% of myeloma patients present at diagnosis with clinical neuropathy although studies reveal as many as 1/3 may have abnormal electrophysiological examinations. Baseline neuropathic abnormal findings are exacerbated by many myeloma treatments, especially bortezomib, thalidomide, and to a lesser extent lenalidomide. Several studies suggest that vitamin D supplementation may help reduce the symptoms of neuropathy.In this prospective study, we will investigate the relationship between vitamin D and PN among MM patients treated with either bortezomib or thalidomide. The study consists of a screening period of up to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic pain, and markers of depression. Patient charts will also be utilized to assess the frequency of skeletal-related events.
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
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Prior diagnosis of multiple myeloma based on standard criteria (Durie 1986)
- •Received consecutive, prior treatment for MM with a regimen consisting of at least 16 consecutive weeks of bortezomib or 16 consecutive weeks of thalidomide prior to the Day of Assessment
- •The 16 weeks of consecutive treatment must have included at least one of the following doses and schedules:
- •Bortezomib: ≥ 1.0 mg/m² dosed 3 or more times per each 4-week period
- •Thalidomide: ≥ 50 mg/day dosed daily
- •The qualifying regimen may include both bortezomib and thalidomide. However, the above inclusion requirements need only be satisfied by either one of the agents.
- •Age ≥18 years at the time of signing the informed consent form
- •Able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome (Bardwick 1980)
- •Plasma cell leukemia
- •Primary amyloidosis
- •Vitamin D level assessment occurring within the 12 months preceding the Day of Assessment
- •Vitamin D non-dietary oral supplementation > 1200 IU per day for > 30 total days within the 12 month period preceding the Day of Assessment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
结局指标
主要结局
Serum vitamin D levels
时间窗: Day 1
Correlation of serum vitamin D levels to the incidence and severity of anti-myeloma treatment-induced PN/ neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide
次要结局
- Skeletal related event(Day 1)