NCT04348006撤回4 期
Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients
Al-Rasheed University College1 个研究点 分布在 1 个国家开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Assessment the safety of Alvocade® therapy
研究概览
简要总结
Bortezomib considered the standard of care for treating multiple myeloma patients, the aim was to assess the safety and efficacy of newly approved drug (Alvocade ®) in Iraq, in newly diagnosed patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions)
- •Age above 18 years old
排除标准
- •Age below 18 years
- •Smoldering MM
研究组 & 干预措施
Induction Therapy
Experimental
Bortezomib will be administered as part of VCD or VRD protocols
干预措施: Bortezomib 3.5 MG (Drug)
结局指标
主要结局
Assessment the safety of Alvocade® therapy
时间窗: During 6 months
Monitoring the rate of any adverse effect/event that will occur during the induction therapy
Assessment the effecacy of Alvocade® therapy
时间窗: At end of 6 months
Assessment of overall response rate (ORR) of treatment after completion of induction protocol
次要结局
- First assessment response(At end of 2 months)
- Second assessment response(At end of 4 months)
- Third assessment response(At end of 6 months)
研究者
研究点 (1)
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