A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 26
- 试验地点
- 24
- 主要终点
- Overall Response Rate
研究概览
简要总结
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years at the time of signing the informed consent document
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
- •Able to adhere to the study visit schedule and other protocol requirements
- •Previously untreated, symptomatic multiple myeloma
- •Have measurable disease by protein electrophoresis analyses
- •At least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Must agree to comply to Lenalidomide Pregnancy Prevention Risk Management Plan
排除标准
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •Any condition that confounds the ability to interpret data from the study
- •Previous treatment with anti-myeloma therapy
- •Pregnant or lactating females
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000/microL (1.0 × 10^9/L )
- •Untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) < 50,000 cells/microL (50 × 10^9/L)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal
- •Renal failure requiring hemodialysis or peritoneal dialysis
- •Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years
- •Subjects who are unable or unwilling to undergo antithrombotic therapy.
- •Peripheral neuropathy of ≥ grade 2 severity.
- •Uncontrolled systemic fungal, bacterial, or viral infection
- •Known human immunodeficiency virus (HIV) positivity (subjects who are receiving antiretroviral therapy for HIV disease)
- •Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.
- •Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
- •Ineligible for dexamethasone or dexamethasone is contraindicated.
研究组 & 干预措施
Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
干预措施: Lenalidomide (Drug)
Lenalidomide plus dexamethasone
Lenalidomide plus low-dose dexamethasone
干预措施: dexamethasone (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.
Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
次要结局
- Duration of Response(From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.)
- Overall Survival (OS)(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months)
- Progression Free Survival (PFS)(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.)
- Number of Participants With Adverse Events(From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks)
- Time to Response(From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.)