EUCTR2015-002993-19-GB进行中（未招募）1 期
An Open-Label Treatment Use Protocol for Daratumumab in Subjects with Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 692
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
- •- Subject must be at least 18 years of age
- •- Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria:
- •Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal
- •to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months)
- •Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For
- •subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one
- •- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1,or 2
- •- A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening
- •- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
- •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 1060
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 940
排除标准
- •- Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab
- •- Subject receives any other anti-myeloma therapy while receiving daratumumab
- •- Enrolled in another interventional clinical study with therapeutic intent
- •- Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal
- •- Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification
- •- Prior exposure to any anti-CD38 monoclonal antibody
研究者
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