Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)
研究概览
简要总结
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
详细描述
MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.
Study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%, respectively).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >=18 years old
- •Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2
- •Myeloma cast nephropathy (MCN)
- •Multiple myeloma
- •Informed consent
- •neutrophils >= 1 Giga/L and platelets >= 70 Giga/L
排除标准
- •Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma
- •Peripheral neuropathy
- •Contraindications to either corticosteroids or Bortezomib
- •Patient refusal
- •Known HIV infection
- •Concomitant severe disease including neoplasias (except basocellular carcinoma)
- •Liver failure, cytolysis, and/or cholestasis
- •Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation)
研究组 & 干预措施
BD
干预措施: Bortezomib +Dexamethasone regimen (Drug)
C-BD
干预措施: Cyclophosphamide + Bortezomib + Dexamethasone regimen (Drug)
HCO
干预措施: Bortezomib +Dexamethasone regimen (Drug)
HCO
干预措施: HCO group (Device)
Control HD
干预措施: Bortezomib +Dexamethasone regimen (Drug)
Control HD
干预措施: conventional high-flux dialyzer (Device)
结局指标
主要结局
Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)
时间窗: 3 months after randomization
* renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2 * the absence of any dialysis requirement will be defined by an eDFG \> 15 ml/min/1.73 m2, 15 days after the last hemodialysis session
次要结局
- Hematological response(after 1 and 3 courses, at the end of chemotherapy and at 1 year)
- Improvement in renal function(after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year)
- Progression free survival (PFS)(4 years)
- Time to treatment Failure (TTF)(4 years)
- Overall survival (OS)(4 years)