NCT01058434已完成2 期
A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 16
- 主要终点
- Overall response rate
研究概览
简要总结
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
- •Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)
- •Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.
- •Presence of measurable disease as defined by at least one of the following;
- •Serum M-protein ≥ 1g/dL (measurable disease)
- •Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)
排除标准
- •Patients with non-secretory, or oligosecretory, multiple myeloma.
- •Patients with symptomatic amyloidosis, or with plasma cell leukemia.
- •Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TKI258
Experimental
干预措施: TKI258 (Drug)
结局指标
主要结局
Overall response rate
时间窗: 4 weeks
次要结局
- Plasma exposure of TKI258(during the first 3 cycles)
- frequency and severity of adverse events as per CTCAE(throughout the study)
- Progression free survival (PFS)(every 4 weeks)
研究者
研究点 (16)
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