ACTRN12615000447550终止2 期
A 2-stage Phase II study evaluating the safety and efficacy of combination pomalidomide and low dose dexamethasone therapy in patients with relapsed myeloma previously treated wtih lenalidomide maintenance post Autologous Stem Cell Transplant (LEOPARD follow-on study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
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
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. 18+ years of age and be able to give informed consent
- •2. Confirmed diagnosis of multiple myeloma with progressive disease as per IMWG criteria
- •3. Patients must have evaluable multiple myeloma with, at least of the following:
- •- serum M-protein greater than or equal to 5g/L, or
- •- urine M-protein greater than or equal to 200mg/24 hour, or
- •- serum free light chain (SFLC) >100mg/L (involved light chain) and an abnormal kappa/lambda ratio (>4:1 or <2:1), or
- •- for IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (total IgA) greater than or equal to 7.5g/L
- •4. Immediate therapy prior to relapse or progressive disease was lenalidomide maintenance as part of the LEOPARD study
- •-Note: Patients who discontinued LEOPARD study due to reasons other than progression (such as toxicity, consent withdrawal) and have subsequent relapse may be eligible for inclusion
- •5. Life expectancy of > 16 weeks
- •6. Patient must be greater than or equal to 7 days from prior focal radiotherapy, and greater than or equal to 2 weeks from last dose of lenalidomide and/or prednisolone, and/or major surgery prior to the first dose of study drug. No other anti-myeloma therapy is given between cessation of RAP maintenance and commencement of Pomalidomide therapy.
- •7. Adequate organ function and absence of any other absolute contraindications to the use of pomalidomide or dexamethasone
- •8. ECOG performance status 0-2
- •9. All women of childbearing potential must agree to have a negative pregnancy test in the 24hrs before commencing pomalidomide, take adequate precautions to prevent pregnancy, and not plan on conceiving children during or within 6 months following pomalidomide
- •10. All males must use barrier contraception during and for 4 weeks after completing pomalidomide.
排除标准
- 未提供
研究者
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