A Phase I Study of JNJ-54761414 (Daratumumab) in Japanese Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLT)
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).
详细描述
This is a Phase 1, open-label (all participants and study personnel will know the identity of the study treatments) and multicenter (study conducted at multiple sites) study in Japanese participants. The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Treatment Phase consists of 2 parts: intense dosing regimen and less intense dosing regimen. Follow-up phase will be until 8 weeks after last dose administration/death/lost to follow up/consent withdrawal for study participation or study end, whichever occurs first. The primary endpoints will be Dose Limiting Toxicity (DLTs) and overall Adverse Events (AEs) profiling. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants proven to have symptomatic (having symptoms) multiple myeloma according the International Myeloma Working Group (IMWG) diagnostic criteria
- •Participant must have measurable disease defined by either or both the following measurements: a) Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter [g/L]) (except for serum immunoglobulin A [IgA] M-protein >= 0.5 g/dL); b) Urine M-protein >=200 milligram per 24 hour (mg/24 h); in case immunoglobulin D [IgD] or immunoglobulin E [IgE] M-protein, quantification should be performed
- •Participant must have relapsed or refractory multiple myeloma after receiving at least 2 previous therapies, and without further established treatment options
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •Participant must have life expectancy greater than (>) 3 months
排除标准
- •Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
- •Participant has received anti-myeloma treatment within 2 weeks before administration of the study drug
- •Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before administration of the study drug
- •Participant has a history of malignancy (other than multiple myeloma) within 5 years before administration of the study drug
- •Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma
研究组 & 干预措施
Daratumumab 8 milligram per kilogram (mg/kg)
Participants will be administered intravenously with daratumumab at a dose of 8 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation.
干预措施: Daratumumab (Drug)
Daratumumab 16 mg/kg
Participants will be administered intravenously with daratumumab at a dose of 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation.
干预措施: Daratumumab (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLT)
时间窗: Day 1 up to Day 36
The Dose-Limiting Toxicities (DLTs) are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or hematologic toxicity.
Number of Participants affected by Adverse Events
时间窗: Baseline up to 4 Weeks after the last dose of study drug administration
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Percentage of Participants With Overall Response(Baseline until disease progression, unmanageable adverse event or death, whichever occurs first, up to 1 year)
- Time to Response(Baseline until first documented response or up to 1 year)