A Phase 1b Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone (DRd) in Japanese Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 主要终点
- Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone
研究概览
简要总结
The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
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 with documented multiple myeloma (MM) satisfying the CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities) criteria , monoclonal plasma cells in the bone marrow more than equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable disease Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G MM: serum monoclonal paraprotein (M protein) level >=1.0 gram/deciliter (dL) or urine M protein level >= 200 milligram(mg)/24 hours; or (b) IgA, IgM, IgD, or IgE MM: serum M protein level >=0.5 g/dL or urine M protein level >=200 mg/24 hours; or (c) Light chain MM without measurable disease in serum or urine: serum Ig free light chain (FLC) >=10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
- •Participants newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to being >=65 years old, or in subjects less than (<) 65 years old presence of important comorbid condition(s) likely to have a negative effect on the tolerability of high-dose chemotherapy with ASCT
- •Pretreatment clinical laboratory values meeting the following criteria during the Screening Phase
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 4 weeks prior to dosing and the second within 3 days prior to dosing
排除标准
- •Participants with diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering MM
- •Participant with plasma cell leukemia or other conditions in which Ig (immunoglobulin) M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- •Participants who have prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
- •Participants with history of malignancy (other than MM) within 5 years before the date of the first daratumumab administration
- •Participants who have radiation therapy within 14 days of the first dose
研究组 & 干预措施
Daratumumab with Lenalidomide and dexamethasone
Daratumumab (16 milligram per kilogram [mg/kg]) will be administered by intravenous [IV] infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle.
Participants will receive dexamethasone 40mg weekly, at day 1, 8, 15, 22 of each cycle.
干预措施: Daratumumab (16 mg/kg) (Drug)
Daratumumab with Lenalidomide and dexamethasone
Daratumumab (16 milligram per kilogram [mg/kg]) will be administered by intravenous [IV] infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle.
Participants will receive dexamethasone 40mg weekly, at day 1, 8, 15, 22 of each cycle.
干预措施: Lenalidomide (Drug)
Daratumumab with Lenalidomide and dexamethasone
Daratumumab (16 milligram per kilogram [mg/kg]) will be administered by intravenous [IV] infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle.
Participants will receive dexamethasone 40mg weekly, at day 1, 8, 15, 22 of each cycle.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT) to analyze the safety of daratumumab when combined with lenalidomide and dexamethasone
时间窗: Cycle 1, Day 1 to Day 28
Number of Participants With Dose Limiting Toxicity During Cycle 1.
次要结局
- Rate of Complete Response (CR) or Better(Approximately 3.7 years)
- Very good partial response (VGPR) or better (VGPR, CR, or sCR)(Approximately 3.7 years)
- Overall Response Rate (ORR)(Approximately 3.7 years)
- Minimum Observed Serum Concentration (Cmin)(Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose))
- Maximum Observed Concentration (Cmax)(Cycle 1, Cycle 3, Cycle 6, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose))
- Immunogenicity of daratumumab(Cycle 1, Cycle 3, Cycle 12 (each cycle of 28 days), End of Treatment (within 30 days of the last dose), and Follow-Up (8 weeks after the last dose))