EUCTR2007-003783-22-DK进行中（未招募）1 期
Daratumumab (HuMax-CD38) safety study in multiple myeloma – Open label, dose-escalation followed by open label, single-arm study - Daratumumab (HuMax-CD38) safety study in multiple myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Documented diagnosis of multiple myeloma requiring systemic therapy
- •2. Age = 18 years.
- •3. ECOG performance status (0-2).
- •4. Life expectancy > 3 months.
- •5. Relapsed or refractory to two or more different prior therapies
- •6. Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Plasma cell leukemia defined as a plasma cell count > 2000/mm3.
- •2. Known amyloidosis
- •3. Patients who previously have received an allogenic stem cell transplant and receive or have received immunosuppressive therapy within the last three months.
研究者
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