A Phase I Study of Lintuzumab-Ac225 in Patients With Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- Maximum Tolerated dose of Lintuzumab-AC225
研究概览
简要总结
- Establish the MTD of Lintuzumab-Ac225 as monotherapy
- Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR)
- Confirm the safety profile of the treatment regimen
- Estimate progression-free survival (PFS) and overall survival
详细描述
The study is a multicenter, open label Phase I trial. Phase 1, dose-escalation : This study uses a 3+3 design to estimate the maximum tolerated dose (MTD).
There will be 3 escalating dose levels in the trial (0.5 μCi/kg, 1 μCi/kg, and 1.5 μCi/kg). Each dose can be administered in up to 3-8 cycles providing that the total dose received per patient does not exceed 4.5 μCi/kg.
De-escalation (decrease dose level to 0.25 μCi/kg) is planned if at the first dose level of 0.5 μCi/kg, after expanding the cohort to a maximum of 6 patients, ≥2 patient have DLTs. At the dose level of 0.25 μCi/kg, if eligible to continue receiving additional doses of the study drug, patients will receive up to 8 doses in total, with the total administered activity being 2 μCi/kg.
The starting dose level will be 0.5 μCi/kg of 225Ac-Lintuzumab administered on day 1 of each cycle. If this dose level is safe, the second dose level of 1 μCi/kg will be explored. If the starting dose level results in DLTs in ≥2 patients, the dose level of 0.25 μCi/kg will be explored.
Subjects will receive the investigational drug as a single infusion at the prescribed dose level.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IV infusion of Lintuzumab AC225
Starting dose - 0.5 μCi/Kg IV infusion of Lintuzumab AC225 on Day 1 of each cycle with dose escalation 1 μCi/Kg and 1.5 μCi/Kg or de-escalation to 0.25 μCi/Kg.
1 cycle = 28 days, up to 3 to 8 cycles (depending on the cohort).
干预措施: Lintuzumab AC 225 (Drug)
结局指标
主要结局
Maximum Tolerated dose of Lintuzumab-AC225
时间窗: Through study completion, an average of 2.5 year
establish the maximum tolerated dose as monotherapy
Adverse events- Treatment Emergent
时间窗: Through study completion, an average of 2.5 year
safety of lintuzumab-Ac225
次要结局
- Overall survival(Through study completion, an average of 2.5 year)
- Progression free survival(Through study completion, an average of 2.5 year)
- Response rates (objective response rate, complete response rate, stringent complete response rate, very good partial response rate and partial response rate)(Through study completion, an average of 2.5 year)