A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 26
- 主要终点
- Response Rate (Complete Response(CR) / Partial Response (PR))
研究概览
简要总结
This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panobinostat
Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
干预措施: LBH589 (Drug)
结局指标
主要结局
Response Rate (Complete Response(CR) / Partial Response (PR))
时间窗: From Start of the Study up to 57 Weeks approximately.
The response (complete response (CR) / partial response (PR)) rate as per Bladé criteria was assessed by the investigator. Response to treatment was evaluated in participants with multiple myeloma (MM) who have received at least two prior lines of therapy and whose disease was refractory to the most recent line of therapy.
次要结局
- Overall Response Rate(From Start of the Study up to 57 Weeks approximately.)
- Duration of Response(From Start of the Study up to 57 Weeks approximately.)
- Time to Response(From Start of the Study up to 57 Weeks approximately.)
- Progression Free Survival (PFS)(From Start of the Study up to 57 Weeks approximately.)
- Time to Peak Concentration (Tmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Clinical Benefit Rate(From Start of the Study up to 57 Weeks approximately.)
- Safety and Tolerability(From Start of the Study up to 57 Weeks approximately.)
- Last Observed Plasma Concentration (Clast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Maximum Plasma Concentration (Cmax) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Area Under the Plasma Concentration (AUC0-24) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)
- Time of Clast (Tlast) of Panobinostat(Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8)