A Phase 1, Open-label, Multicenter Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Chinese Subjects With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 5
- 主要终点
- Number of participants with Adverse Events (AEs) and Serious AEs
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.
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
- •Multiple myeloma (MM) diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •Participants must have measurable, secretory disease as defined by any of the following:
- •Serum monoclonal paraprotein (M-protein) level greater than or equal to(>=)1.0 gram/deciliter (g/dL) or >= 0.5 g/dL for Immunoglobulin (Ig) A, IgD, IgE or IgM MM; or
- •Urine M-protein level >= 200 milligram (mg)/24 hours; or
- •Serum Ig free light chain (FLC) >= 10 mg/dL and abnormal serum Ig kappa lambda FLC ratio if participant does not have measurable M-protein in serum and urine
- •Relapsed or refractory MM after receiving at least 2 prior lines of therapy: Received both, a PI (>=2 cycles or 2 months of treatment) and an IMiD (>=2 cycles or 2 months of treatment)in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months); A "line of therapy" is defined as 1 or more cycles of a planned treatment program, Radiotherapy, bisphosphonate therapy, or a single short course of steroids (that is, less than or equal to equivalent of cumulative dose of dexamethasone 160 mg within 21 days of 1st dose) would not be considered prior lines of therapy
- •Response (partial response or better based on investigator's determination of response) to at least 1 prior treatment regimen
- •Progressive disease based on investigator's determination of response on or after their last regimen
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Participant has received daratumumab or other anti-CD38 therapies previously
- •Participant has received prior antitumor therapy as follows, prior to the first dose of study drug:
- •Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less;
- •Monoclonal antibody treatment for multiple myeloma within 21 days;
- •Cytotoxic therapy within 21 days;
- •Proteasome inhibitor therapy within 14 days;
- •Immunomodulatory agent therapy within 7 days;
- •Radiotherapy within 21 days. However, if the radiation portal covered less than or equal to (<=) 5 percent (%) of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy
- •Participant has had a plasmapheresis within 28 days before Cycle 1 Day 1
- •Participant has known meningeal or central nervous system involvement of MM
- •Concurrent medical condition or disease (example [e.g.], active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
研究组 & 干预措施
Daratumumab
Participants will receive daratumumab dose 1 subcutaneously (SC) with recombinant human hyaluronidase [rHuPH20] 30,000 units [U] that is 2,000 U/milliliter (U/mL) SC injection once weekly for the first 8 weeks Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks Cycles 3 to 6 (Days 1 and 15) or the following 16 weeks and then every 4 weeks from Cycle 7 [Day 1] in subsequent cycles, until disease progression, unacceptable toxicity, or any other reason for discontinuation. Each cycle is 28 days in duration.
干预措施: Daratumumab (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs) and Serious AEs
时间窗: Up to 2 years
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is 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.
Maximum Observed Serum Concentration (Cmax) of Daratumumab
时间窗: Day 1 (2 hours, 12 hours) Cycle 1 (each cycle is of 28 days)
Cmax is the maximum observed serum concentration.
Serum Trough Concentration (Ctrough) of Daratumumab
时间窗: At Day 1 Cycle 3 predose concentration (each cycle is of 28 days)
Ctrough is the observed concentration of daratumumab prior to the next drug administration.
次要结局
- Duration of Response (DOR)(Up to 2 years)
- Overall Response Rate (ORR)(Up to 2 years)
- Time to Response(Up to 2 years)
- Serum Concentration of Daratumumab and Recombinant Human Hyaluronidase (rHuPH20) (Plasma) Antibodies(Up to 2 years)