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临床试验/NCT07206810
NCT07206810已完成不适用

A Study of the Bortezomib, Lenalidomide, and Dexamethasone (VRD) Regimen for the Treatment of Newly Diagnosed Multiple Myeloma Patients

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 419 人开始时间: 2018年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
419
试验地点
1
主要终点
response

研究概览

简要总结

A real-world prospective registry study for patients with newly diagnosed multiple myeloma (NDMM) has been conducted at the First Affiliated Hospital of Soochow University since August 2018. Diagnosis, staging, treatment response assessment, and risk stratification of MM were performed in accordance with the International Myeloma Working Group (IMWG) guidelines. In this study, transplant-eligible patients underwent autologous hematopoietic stem cell transplantation (auto-HSCT) after four cycles of VRD induction therapy, followed by two cycles of VRD consolidation therapy. Chemotherapy was administered in 28-day cycles as follows: subcutaneous bortezomib 1.3 mg/m² on days 1, 4, 8, and 11; oral lenalidomide 25 mg/day (or a dose-adjusted 10 mg based on renal function) from days 1 to 14; and intravenous dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12. Standard-risk patients received oral lenalidomide as maintenance therapy until disease progression. High-risk patients, defined as those with t(4;14), t(14;16), or del(17p), received bortezomib plus lenalidomide (V+R) as maintenance therapy until disease progression. Enrolled patients had complete clinical information at the time of initial diagnosis and received at least two cycles of VRD therapy. Frailty assessments were conducted prior to each chemotherapy cycle. The study protocol specified the following lenalidomide dosing based on renal function: patients with eGFR ≥60 ml/min/1.73 m² received oral lenalidomide 25 mg/day; those with 30 ml/min/1.73 m² ≤ eGFR < 60 ml/min/1.73 m² received oral lenalidomide 10 mg/day; and those with eGFR < 30 ml/min/1.73 m² or who were dialysis-dependent received oral lenalidomide 10 mg every other day. Long-term follow-up was performed to monitor treatment efficacy and survival status.

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

入选标准

  • (1) diagnosis of active multiple myeloma according to the IMWG criteria; (2) age over 18 years; (3) newly diagnosed and treatment-naïve; (4) availability of complete clinical information; (5) receipt of at least two cycles of VRD regimen; and (6) regular follow-up at our department.

排除标准

  • (1) follow-up duration of less than 6 months; (2) incomplete clinical data; and (3) failure to receive regular treatment in our department.

结局指标

主要结局

response

时间窗: before auto-HSCT

sCR, CR, VGPR, PR, SD, PD

次要结局

未报告次要终点

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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