EUCTR2009-010956-93-GB进行中（未招募）不适用
Randomised comparisons, in myeloma patients of all ages, of thalidomide, lenalidomide, carfilzomib and bortezomib induction combinations, and of lenalidomide and combination lenalidomide vorinostat as maintenance - Myeloma XI
niversity of Leeds0 个研究点目标入组 4,000 人开始时间: 2009年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,000
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
- •1. Aged 18 years or greater 2. Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple myeloma based on: o Paraprotein (M-protein) in serum and/or urine o Bone marrow clonal plasma cells or plasmacytoma o Related organ or tissue impairment and/or symptoms considered by the clinician to be myeloma related 3. Provide written informed consent 4. Women of childbearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use contraception in accordance with (and consent to) the Celgene approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention, or commit to absolute and continuous abstinence. 5. Women of child bearing potential must have a negative pregnancy test in accordance with the Celgene approved process for thalidomide and lenalidomide Risk Management and Pregnancy Prevention
- •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
- •1. Asymptomatic myeloma 2. Solitary plasmacytoma of bone. (Patients with previous solitary plasmacytoma that have now progressed to symptomatic or non-secretory myeloma are eligible). 3. Extramedullary plasmacytoma (without evidence of myeloma) 4. Previous (<5 years since diagnosis) or concurrent active malignancies, except* surgically-removed basal or squamous cell carcinoma of the skin, treated carcinoma in situ of the breast of cervix, or incidental histologic finding of prostate cancer (TMN stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered.* *Entry of patients with the permitted previous malignancies is at the discretion of the local investigator, in light of the potential increased risk of second malignancy in patients treated with lenalidomide. 5. Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for high-risk disease 6. Previous treatment for myeloma, except the following: o local radiotherapy to relieve bone pain or spinal cord compression o prior bisphosphonate treatment o corticosteroids 6. Known history of allergy contributable to compounds containing boron or mannitol 7. Grade 2 or greater (NCI criteria) peripheral neuropathy 8. Caution is advised in patients with a past history of ischaemic heart disease, pericardial disease, acute diffuse infiltrative pulmonary disease or psychiatric disorders, evidence of impaired marrow function or elevated liver function tests, but exclusion is essentially to be at the discretion of the treating clinician 9. Acute renal failure (unresponsive to up to 72 hours of rehydration, characterised by creatinine >500µmol/l or urine output <400ml/day or requirement for dialysis) 10. Lactating or breastfeeding
研究者
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