A Clinical Study on the Whole-course Management (BCD-KPD-AutoHSCT) Scheme for Patients With Multiple Myeloma and Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- renal response rates
研究概览
简要总结
Multiple myeloma (MM) is still an incurable hematological tumor, and renal involvement is the main factor of poor prognosis. The recovery of renal function can partially reverse its poor outcome. Although the 5-year survival rate of MM patients has significantly improved after entering the era of new drugs, patients with severe renal insufficiency still have a high early mortality.The purpose of this study is to investigate whether early intensive chemotherapy can reverse the proportion of renal insufficiency, is to investigate the treatment effect of RIMM patients with different renal pathological types, and is also to investigate whether autoHSCT can further partially save renal function in RIMM patients.
详细描述
For patients with multiple myeloma with renal impairment, the same disease stage and the same treatment regimen have different therapeutic effects. In the era of new drugs, studies have shown that early reduction of the free light chain in serum is the key to reversing renal function. The International Myeloma Working Group recommends the following drugs for the treatment of RIMM patients: 1. regimens based on proteasome inhibitors; 2. regimens based on immunomodulators. Here, we explore a clinical study on the Whole-course Management (BCD-KPD-AutoHSCT) scheme for patients with RIMM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Confirmed diagnosis of symptomatic myeloma with renal impairment
- •Confirmed myeloma-associated nephropathy (e.g. light chain cast nephropathy, AL amyloidosis, MIDD etc.) on renal biopsy
- •Willingness and eligibility for autologous hematopoietic stem cell transplantation
排除标准
- •Pre-existing chronic kidney disease unrelated to myeloma, such as diabetic nephropathy or hypertensive nephropathy
- •Plasma cell leukemia or extramedullary plasmacytoma
- •Contraindications or prior severe allergic reactions to study medications
- •Co-existing malignancy
- •Co-existing medical conditions unsuitable for enrollment as determined by researchers, such as recent cardiovascular event, active infection etc.
研究组 & 干预措施
BCD-KPD-AutoHSCT
BCD-KPD-AutoHSCT/BCD-AutoHSCT
干预措施: Bortezomib (Drug)
结局指标
主要结局
renal response rates
时间窗: 2 years
次要结局
未报告次要终点
研究者
Yujun DONG
chief of department of hematology
Peking University First Hospital