NCT01122875已完成1 期
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0, 1, or 2
- •Life expectancy of at least 12 weeks
- •Histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists
排除标准
- •Prior use of any monoclonal antibody before study treatment
- •Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment
- •Completion of autologous stem cell transplant within 6 months prior to study treatment
- •Prior allogeneic stem cell transplant
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- •Evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with IV antibiotics or hospitalization prior to study treatment
- •Recent major surgery (prior to study treatment), other than for diagnosis
- •Presence of positive test results for Hepatitis B or Hepatitis C
- •Known history of HIV seropositive status
- •Women who are pregnant or lactating
- •Childbearing potential without agreement to use effective form of contraception for the duration of the study
研究组 & 干预措施
A
Experimental
干预措施: MFGR1877S (Drug)
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Throughout study or until early study discontinuation
次要结局
- Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)(Throughout study or until early study discontinuation)
- Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)(Throughout study or until early study discontinuation)
- Incidence, nature, and severity of adverse events(Throughout study or until early study discontinuation)
研究者
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