NCT05561049尚未招募不适用
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study
The First Affiliated Hospital of Soochow University0 个研究点目标入组 120 人开始时间: 2022年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Very good partial response (VGPR) rate
研究概览
简要总结
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •newly diagnosed multiple myeloma;
- •age over 18 years, male or female;
- •glomerular filtration rate (eGFR) < 40 mL/min
- •Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
- •patients who completed at least one course of treatment were included in the safety observation;
- •Patients who completed at least 2 courses of treatment were included in the efficacy observation;
排除标准
- •acute and chronic renal insufficiency not caused by myeloma;
- •are receiving any other investigational drug or investigational medical device;
- •Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
- •patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;
结局指标
主要结局
Very good partial response (VGPR) rate
时间窗: 28 days after consolidation therapy
次要结局
未报告次要终点
研究者
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