An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- The Maximum Tolerated Dose (MTD) of BI 836909
研究概览
简要总结
The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for further development will be determined. This will depend on the safety data, pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary objectives are to document the safety and tolerability of BI 836909, to perform pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in terms of parameters of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（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
Intravenous Infusion of BI 836909 (0.2 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (0.4 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (0.8 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (1.6 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (3.2 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (6.5 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (13 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (25 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (50 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (100 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (200 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (400 μg/d)
干预措施: BI 836909 (Drug)
Intravenous Infusion of BI 836909 (800 μg/d)
干预措施: BI 836909 (Drug)
结局指标
主要结局
The Maximum Tolerated Dose (MTD) of BI 836909
时间窗: Cycle 1, up to 6 weeks.
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
The Number of Patients With Dose-limiting Toxicities (DLTs)
时间窗: Cycle 1, up to 6 weeks.
The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
次要结局
- Number of Participants With an Objective Response(On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.)
- Duration of Objective Response - on Treatment(From start of treatment till end of trial (EOT) visit, up to 61 weeks.)
- Duration of Objective Response - Including Extended Follow up Visits(From start of treatment till the last extended follow-up visit which is scheduled at 12 months after end of treatment, up to 113 weeks.)
- Number of Participants With a Minimal Residual Disease (MRD) Response(On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.)
- Duration of Minimal Residual Disease (MRD) Response - on Treatment(From start of treatment till end of trial (EOT) visit, up to 61 weeks.)
- Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits(From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.)
- Progression-free Survival (PFS) - on Treatment(From start of treatment till end of trial (EOT) visit, up to 61 weeks.)
- Progression-free Survival (PFS) - Including Extended Follow up Visits(From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.)
- Serum Concentration at Steady State of BI 836909 (Css)(Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.)