A Randomised Comparison of Daily 25 mg Versus 5 mg Lenalidomide as Maintenance Therapy After High-dose Therapy and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 5
- 主要终点
- event-free survival
研究概览
简要总结
This trial is a randomised, parallel-group, multicenter phase III study for maintenance therapy with lenalidomide in patients with multiple myeloma who were treated with high-dose therapy and autologous stem cell transplantation as first line therapy.
详细描述
High-dose therapy will be performed as first line treatment. After high-dose therapy and autologous stem cell transplantation the patients will be included and randomised. Three month after high-dose therapy all patients will receive consolidation therapy with 6 cycles of lenalidomide 25 mg daily for 21 days every 28 days. Afterwards patients will receive maintenance therapy according to their assigned treatment arm. Randomisation will be performed in a 1:1 ratio to continuous maintenance therapy with either 25mg or 5mg lenalidomide daily for 21 days every 28 days.Randomisation will be stratified by ISS-stage (1+2 vs 3, age (younger than 66 years versus 66 years or older), response after high-dose therapy (CR+vgPR vs PR vs MR/SD. Patients will be treated until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Age 18-75 years
- •Able to adhere to the study visit schedule and other protocol requirements
- •Patients with multiple myeloma who have received high-dose therapy and autologous stem cell transplantation as first-line therapy within the last 90 - 120 days and have not shown progressive disease afterwards.
- •Patients may have received up to 6 cycles of prior induction therapy and up to 2 cycles of prior mobilisation chemotherapy. A bortezomib or thalidomide induction therapy is allowed. Patients may also have received prior radiation therapy
- •Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g/24hours) or measurable free light chains (FLC) in serum (>50 mg/l) with an abnormal FLC ratio must be documented at the time of first diagnosis.
- •ECOG performance status = 2 at study entry
- •Laboratory and functional test results within these ranges:
- •ANC ≥ 1,000/μL
- •Platelet count ≥ 100,000/μL
- •Total bilirubin 2.5 mg/dL
- •AST (SGOT) and ALT (SGPT) 3 x ULN
- •Patients with impaired renal function can be included
- •The patient must be able to adhere to the pregnancy precautions
- •Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- •Pregnant or breast feeding females
- •Any condition or laboratory abnormality which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Known allergic/hypersensitivity reaction to thalidomide, lenalidomide or any components of the treatment
- •Any cutaneous grade ≥ 3 adverse reaction (for example desquamating rash) while taking thalidomide or similar drugs
- •Any prior use of lenalidomide
- •Known positive for HIV or active infectious hepatitis, type A, B or C
研究组 & 干预措施
1
25 mg lenalidomide
干预措施: Lenalidomide (Drug)
2
5 mg lenalidomide
干预措施: Lenalidomide (Drug)
结局指标
主要结局
event-free survival
时间窗: 6 years
次要结局
- safety, tolerability and feasibility(6 month)
- Improvement of remission rate(6 years)
- evaluate quality of life(6 years)