PRAGMMATIC: A Comparative Clinical Trial to Determine the BEST Initial Therapy for Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Overall survival
研究概览
简要总结
This study evaluates the outcomes of patients undergoing initial therapy for multiple myeloma.
详细描述
PRIMARY OBJECTIVE:
I. Compare the overall survival between bortezomib, lenalidomide and dexamethasone (VRd), daratumumab, lenalidomide and dexamethasone (DRd) and daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) used as initial therapy for patients with newly diagnosed MM.
OUTLINE: This is an observational study.
Patients have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated active multiple myeloma starting a new treatment for the disease with one of the three established treatment regimens: VRd (bortezomib, lenalidomide, dexamethasone), DRd (daratumumab lenalidomide dexamethasone), or DVRd (daratumumab, bortezomib, lenalidomide, and dexamethasone)
- •No prior treatment for myeloma
- •Not receiving concurrent treatment for another active malignancy
- •No more than 3 months from start of treatment
排除标准
- •Does not meet all inclusion criteria
结局指标
主要结局
Overall survival
时间窗: Every 3 months, up to 10 years
Overall survival, defined as the time from initiation of therapy to the time of death due to any cause, will be assessed by review of medical record, contacting the participant, or contacting the participant's local physician every 3 months for up to 10 years after participant starts the study.
次要结局
未报告次要终点