Diagnostic Performance of Spot Urine Sample for the Monoclonal Components Detection in Patients With Multiple Myeloma RHU(M)M Random or H24 Urine in (Multiple) Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 36
- 主要终点
- Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample
研究概览
简要总结
The primary objective of the study is to evaluate at Day 1 Cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with Multiple Myeloma.
详细描述
To evaluate the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in Multiple Myeloma patients.
180 evaluable patients are required. For each of them, both spot urine sample and 24h urine sample will be collected at Cycle1 Day1, Cycle 2 Day 1 and Cycle 4 Day 1.
The detection of urine monoclonal component will be performed by urine protein electrophoresis (quantitative) and urine immunofixation (qualitative).
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
- •Patient with Multiple Myeloma
- •Patient starting new treatment line, whatever the line is, but with at least 3 induction cycles
- •Urine monoclonal component ≥ 200mg/24h
排除标准
- •Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision
研究组 & 干预措施
Patients
Cycle1 day1: collection of 24h urine and an urine sample from miction the day of the visit.
Cycle 2 day1:collection of 24h urine and an urine sample from miction the day of the visit Cycle 4 day 1: collection of 24h urine and an urine sample from miction the day of the visit.
干预措施: Detection of monoclonal component (Diagnostic Test)
结局指标
主要结局
Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample
时间窗: at the first Day of Cycle n°2 (each cycle is 28 days or 21 days)
Evaluate the detection sensitivity of the urine monoclonal component on spot urine sample compared to the reference measurement of 24 hours urine. Sensitivity is defined as the proportion, among the patients with positive urinalysis results on 24 hours urine, of positive results on spot urine sample. Evaluation is performed by urine protein electrophoresis and urine immunofixation
次要结局
- Evaluate the specificity of urine monoclonal component detection on spot urine sample(at the first Day of cycle n°2 (each cycle is 28 days or 21 days))
- Evaluate the sensitivity and specificity of urine monoclonal component detection on spot urine sample(at the first day of cycle n°1 and cycle n°4 (each cycle is 28 days or 21 days))
- Define the equivalent of 200 mg / 24H (current consensus threshold of measurable urinary disease)(at the first day of cycle n° 1 (each cycle is 28 days or 21 days))
- Assess the association between the rate of serum light chains and concentration of monoclonal components(at first day of cycle 2 (each cycle is 28 days or 21 days))
- Compare the responses rate(at the first day of cycle n° 2 and cycle 4 (each cycle is 28 days or 21 days))
- Compare the monoclonal component / creatininuria ratios(at the first day of cycle n° 1,2 and 4)
- Evaluate the urine monoclonal component by the difference between proteinuria and albuminuria(at first day of cycle 2 (each cycle is 28 days or 21 days))