jRCT2061220045进行中（未招募）不适用
Phase I study of RO7187797 in patients with Multiple myeloma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) is 0 or
- •Survival of at least 12 weeks after the date of enrollment was judged to be possible.
- •Relapsed/refractory multiple myeloma for which standard therapy is ineffective and inappropriate.
排除标准
- •They have a history of the following immune-mediated side effects of previous immunotherapy:
- •Adverse events Grade 3 or more observed with treatment with anti PD-L1, anti PD-1, or anti CTLA4 therapeutic Abs. Except for Grade 3 endocrine disorders that can be managed with alternative therapies
- •Allogeneic stem cell transplantation was performed in the past.
- •Plasma cell count in peripheral blood exceeds 500/micro liter or plasma cell ratio in differential white blood cell count exceeds 5%.
结局指标
主要结局
-
Safety, Phamacokinetics Adverse events Dose limiting toxicity pharmacokinetic parameters
次要结局
未报告次要终点
研究者
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