NCT05203003招募中不适用
Prospective Evaluation of the Prognostic Impact of Measurable Residual Disease (MRD) Within a Phase III Study Comparing a Fixed Duration Therapy Versus Continuous Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma Requiring a First Salvage Treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Rate of patients that maintain MRD negativity
研究概览
简要总结
We propose to conduct an ancillary prospective evaluation of the impact of Dara-Len-Dex discontinuation after 2 years, on the persistence of MRD negativity in patients that were MRD negative at 2 years.
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
- •Adult patients (≥ 18 years old) who are included in the CONFIRM phase III trial (ClinicalTrials.gov Identifier: NCT03836014).
- •Subject that are still under therapy at 2 years (+/- 3 month) after randomization, either in the fixed duration therapy group or in the continuous therapy group of the CONFIRM protocol
- •Subject in complete response at 2 years (+/- 3 month) after randomization.
- •Signed informed consent
- •Affiliation to a social security system or equivalent
排除标准
- 未提供
结局指标
主要结局
Rate of patients that maintain MRD negativity
时间窗: 3 and 4 years after inclusion
Rate of patients that maintain MRD negativity at 3 and 4 years after inclusion in the current protocol in the continuous Dara-Len-Dex therapy group versus fixed duration Dara-Len-Dex therapy (2 years) group.
次要结局
- PFS at 2 years(2 years)
研究者
研究点 (1)
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