ACTRN12611000597998招募中2 期
A phase II study of lenalidomide and prednisolone as post-ASCT maintenance therapy for patients with Multiple Myeloma incorporating residual disease monitoring.
Malignant haematology and stem cell transplant Service0 个研究点目标入组 40 人开始时间: 2011年6月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 17 Years 至 o limit（—）
- 性别
- All
入选标准
- •At registration pre-ASCT
- •-Age over 17 years
- •-Diagnosis of multiple myeloma as per IMWG
- •-No more than 12 months total prior standard-
- •dose chemotherapy.
- •-No previous high-dose chemotherapy or
- •autologous transplantation procedure.
- •-ECOG performance status 0, 1, or 2.
- •-Normal liver and kidney function (within 2 x the
- •institutional upper limit of normal).
- •-No contraindication to the use of any of the study
- •-Greater than or equal to 2.0 x 106/kg CD34+ stem cells available for
- •-Written informed consent.
- •To commence RAP post-ASCT
- •-Have reached Day 42 post-ASCT with evidence of
- •haemopoietic reconstitution (neutrophils > 1.5 x 109/litre
- •and platelets unsupported >50 x 109/litre).
- •-No evidence of progressive myeloma.
- •-All women of childbearing potential must agree to
- •have a negative pregnancy test in the 24hrs before
- •commencing lenalidomide,
- •take adequate precautions to prevent pregnancy,
- •not plan on conceiving children during or within 6 months
- •following lenalidomide.
- •-All male participants must use barrier contraception during
- •and for 4 weeks after completion of lenalidomide.
- •-No contraindication to prednisolone or lenalidomide
- •-Have an ECOG performance status of 0 – 2.
排除标准
- •-Patients with monoclonal gammopathy of uncertain
- •significance.
- •-Patients with progressive MM pre or post stem cell
- •transplant.
- •-Patients whose general condition makes them unsuitable
- •for intensive treatment e.g. significant cardiac or
- •pulmonary disease.
- •-Active infections or other illnesses that would preclude
- •conditioning chemotherapy or maintenance therapy
- •administration or patient compliance.
- •-Pregnant or lactating women.
研究者
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