EUCTR2007-003945-33-DE进行中（未招募）1 期
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. - LenaMain
Gesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)0 个研究点开始时间: 2008年7月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Understand and voluntarily sign an informed consent form.
- •- Age 18-75 years at the time of signing the informed consent form.
- •- 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 a second high-dose therapy in case of less than a vgPR or due to conditioning with intermediate dose melphalan because of an age of more than 65 years.
- •- Patients may have received up to 6 cycles of prior induction therapy (e.g. idarubicine, dexamethasone) and up to 2 cycles of prior mobilisation chemotherapy (e.g. cyclophosphamide). A bortezomib or thalidomide containing induction therapy is allowed. Patients may also have received prior radiation therapy. The use of lenalidomide as monotherapy or as part of a combination treatment for induction therapy is not allowed.
- •- 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 of £ 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 94
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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. (Lactating females must agree not to breast feed while taking lenalidomide).
- •- 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 hypersensitivity to thalidomide.
- •- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •- Any prior use of thalidomide or lenalidomide.
- •- Known positive for HIV or active infectious hepatitis, type A, B or C.
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