A Phase 1b Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Patients With Relapsed or Refractory Multiple Myeloma (MM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414 (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma.
详细描述
This is an 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 (21 days prior to Cycle 1 Day 1); open-label treatment phase (from Cycle 1 Day 1 until study treatment discontinuation, disease progression, unacceptable toxicity, or other reasons), and a Follow-up Phase. Bortezomib and Dexamethasone will be administered along with JNJ-54767414 for first 8 treatment cycles. Follow-up Phase begins immediately following the End-of-Treatment Visit, and will continue until 8 weeks after last study treatment, death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. Participants' safety will be monitored throughout the study.
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
- 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 (MM) according the International Myeloma Working Group (IMWG) diagnostic criteria
- •Participant must have documented MM as defined by following criteria: Monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter [g/L]) b) Serum immunoglobulin A [IgA] M-protein >= 0.5 g/dL); c) Urine M-protein >=200 milligram per 24 hour (mg/24 h); d) Serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •Participant must have received at least 1 prior line of therapy for MM
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Participant must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen
排除标准
- •Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
- •Is refractory to bortezomib or another PI, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another PI therapy, like ixazomib and carfilzomib
- •Is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
- •Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM)
- •Has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
- •Has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures
研究组 & 干预措施
JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
Participants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles.
干预措施: JNJ-54767414 (Daratumumab) (Drug)
JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
Participants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles.
干预措施: Bortezomib (Drug)
JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
Participants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Approximately 2 years
An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Serum Concentration of JNJ-54767414 (Daratumumab) Antibodies(Approximately 2 years)
- Time to Response(Approximately 2 years)
- Percentage of Participants with a Very Good Partial Response (VGPR) or better(Approximately 2 years)
- Minimum Observed Serum Concentration (Cmin) of JNJ-54767414 (Daratumumab)(Approximately 2 years)
- Maximum Observed Serum Concentration (Cmax) of JNJ-54767414 (Daratumumab)(Approximately 2 years)
- Percentage of Participants with Complete Response (CR) or better(Approximately 2 years)
- Percentage of Participants With Overall Response Rate (ORR)(Approximately 2 years)