An Open Label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- Phase 1: Percentage of Participants With Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).
详细描述
The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.
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
- •(Part 1) Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with lenalidomide and dexamethasone (Len/Dex)
- •(Part 2) Have received at least 1 prior line of therapy for multiple myeloma
- •Be older than or be 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
- •Provide signed informed consent after receipt of oral and written information about the study and before any study-related activity is performed
排除标准
- •Have previously received an allogenic stem cell transplant
- •Have received autologous stem cell transplant within 12 weeks before the first infusion
- •Have received antimyeloma treatment, radiotherapy, or any experimental drug or therapy within 2 weeks before the first infusion
- •Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide. Refractory to lenalidomide is defined as either, participants whose disease progresses within 60 days of lenalidomide, or participants whose disease is nonresponsive while on any dose of lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an minimal response (MR) or development of progressive disease (PD) while on lenalidomide
研究组 & 干预措施
Daratumumab
Participants will receive daratumumab along with Lenalidomide and dexamethasone.
干预措施: Lenalidomide (Drug)
Daratumumab
Participants will receive daratumumab along with Lenalidomide and dexamethasone.
干预措施: Dexamethasone (Drug)
Daratumumab
Participants will receive daratumumab along with Lenalidomide and dexamethasone.
干预措施: Part 1 (Dose Escalation): Daratumumab (Drug)
Daratumumab
Participants will receive daratumumab along with Lenalidomide and dexamethasone.
干预措施: Part 2 (Dose Expansion): Daratumumab (Drug)
结局指标
主要结局
Phase 1: Percentage of Participants With Overall Response Rate (ORR)
时间窗: Up to 3 years
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
Phase 2: Percentage of Participants With Overall Response Rate (ORR)
时间窗: Up to 3 years
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
次要结局
- Phase 2: Time to Response(Up to 5 years)
- Phase 2: Time to Progression (TTP)(Up to 5 years)
- Phase 2: Duration of Response(Up to 5 years)
- Phase 1: Time to Response(Up to 5 years)
- Phase 2: Progression-Free Survival (PFS)(Up to 5 years)
- Phase 2: Overall Survival (OS)(Up to 5 years)