ACTRN12616000777493已完成2 期
Safety and tolerability of lenalidomide consolidation post allogeneic stem cell transplant for patients with high risk multiple myeloma failing to achieve stringent Complete Response
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
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
- •Pre allo-SCT
- •1. Age >18 years of age
- •2. Diagnosis of multiple myeloma as per IMWG criteria:
- •a. Clonal plasma cells greater than 10%
- •b. Presence of serum and/or urinary monoclonal protein (except in patients with true non-secretory multiple myeloma), and
- •c. Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- •i.[C] Hypercalcaemia: serum calcium greater than or equal to 11.5mg/100ml or
- •ii.[R] Renal insufficiency: serum creatinine > 173 micro mol/l or
- •iii.[A] Anaemia: normocytic, normochromic with a haemoglobin value of >20g/l below the lower limit of normal or a haemoglobin value <100g/l or
- •iv.[B] Bone lesions: lytic lesions, severe osteopenia or pathologic fractures.
- •3. Plan to undergo tandem autologous and allogeneic SCT
- •4. No known contraindication to study drugs
- •Post allo-SCT -
- •5. ECOG 0-2
- •6. Undergone tandem autologous and allogeneic SCT
- •7. Reached day 180 post allogeneic SCT AND be off all immunosuppression (including systemic steroids) for >2 weeks AND have failed to achieve stringent complete response.
- •8. Adequate renal function (<2 x institutional upper limit of normal)
- •9. Adequate liver function (<3 x institutional upper limit of normal)
- •10. Platelet count > 75 x 10^9, absolute neutrophils count > 1.5 x 10^9
- •11. Patient has voluntarily agreed and has given written informed consent
- •12. All women of childbearing potential (WOCBP)** must agree to have two negative pregnancy tests (the 1st pregnancy test must be done 10-14 days and 2nd must be done within 24 hours of commencing lenalidomide) before commencing lenalidomide and use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study:
- •1) for at least 28 days before starting study;
- •2) while participating in the study;
- •3) dose interruptions; and
- •4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method.
- •All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
排除标准
- •Post allo-SCT
- •1. Current active graft versus host disease (acute or chronic) requiring immunosuppression
- •2. Prior acute graft versus host disease grade II-IV
- •3. Received donor lymphocyte infusion (DLI) within 8 weeks of commencing study drug
- •4. Uncontrolled medical illness or infections
- •5. Relapsed/progressive myeloma
研究者
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