EUCTR2015-001355-76-GB进行中（未招募）1 期
Phase III randomised trial of immunomodulatory therapy in high risk solitary bone plasmacytoma - IDRIS
niversity College London0 个研究点目标入组 140 人开始时间: 2016年3月31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
- 入组人数
- 140
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
- •INCLUSION CRITERIA FOR REGISTRATION:
- •1. Patients with newly-diagnosed SBP as defined by IMWG and BCSH guidelines that has been confirmed histologically
- •2. Treated or being treated with local radiotherapy as per BCSH guidelines
- •3. Age =18 years
- •4. ECOG performance status 0-2
- •5. Written informed consent
- •6. Willing to comply with the requirements of the Celgene pregnancy prevention programme
- •INCLUSION CRITERIA FOR RANDOMISATION:
- •1. Patients who have one or both of the high risk features will be eligible for randomisation:
- •- Phenotypically aberrant plasma cells in a BM aspirate taken from a site outside the radiotherapy field and/or
- •- Abnormal serum free light chain ratio at diagnosis or the next possible time point if not collected at diagnosis (determined by local reference ranges)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •EXCLUSION CRITERIA FOR REGISTRATION:
- •1. Multifocal plasmacytoma, solitary extramedullary plasmacytoma or myeloma
- •2. =10% bone marrow plasma cells
- •3. On, or planned for, systemic steroid therapy (e.g. dexamethasone or prednisolone) unless otherwise agreed by the TMG
- •4. Severe hepatic impairment (bilirubin >2xULN or AST/ALT >2xULN)
- •5. Creatinine clearance <30mL/min
- •6. Pregnant or lactating women
- •7. Non-haematological malignancy within the past 3 years (exceptions apply – see section 6.2.2)
- •8. Patients at a high risk of venous thromboembolism due to:
- •-Treatment with erythropoietic stimulating agents (e.g. erythropoetin, epoetin alpha, neo- recormon, aranesp)
- •-Other risk factors not listed above
- •9. Patients with untreated osteoporosis
- •10. Patients with uncontrolled diabetes
- •11. Patients with glaucoma
- •12. Any other medical or psychiatric condition likely to interfere with study participation
- •13. Receiving treatment with an experimental drug or experimental medical device. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. Any experimental drug treatments must be stopped within 4 weeks of planned start of lenalidomide and dexamethasone.
- •14. Evidence of current or past hepatitis B infection.
- •15. Uncontrolled active systemic infection.
- •EXCLUSION CRITERIA FOR RANDOMISATION:
- •1. Receiving or intention to treat with systemic corticosteroid therapy (e.g. Dexamethasone) unless otherwise agreed by the TMG.
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