ISRCTN49407852已完成3 期
Randomised comparisons, in myeloma patients of all ages, of thalidomide, lenalidomide, carfilzomib and bortezomib induction combinations, and of lenalidomide and combination lenalidomide plus vorinostat as maintenance
niversity of Leeds (UK)0 个研究点目标入组 4,400 人开始时间: 2009年6月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,400
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30559051 results for maintenance therapy with lenalidomide versus placebo 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31624047 response-adapted intensification treatment results (added 21/10/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33232472/ renal outcome results (added 25/11/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33262523/ results (added 03/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33428632/ results (added 12/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18 years or greater, either sex
- •2. Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple myeloma based on:
- •2.1. Paraprotein (M-protein) in serum and/or urine
- •2.2. Bone marrow clonal plasma cells or plasmacytoma
- •2.3. 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
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 or concurrent active malignancies, except surgically-removed basal cell carcinoma of the skin or other in situ carcinomas. Patients with remote histories (greater than 5 years) of other cured malignancies may be entered.
- •5. Previous treatment for myeloma, except the following:
- •5.1. Local radiotherapy to relieve bone pain or spinal cord compression
- •5.2. Prior bisphosphonate treatment
- •5.3. Corticosteroids within the last 3 months
- •6. Known history of allergy contributable to compounds containing boron or mannitol
- •7. Grade 2 or greater (National Cancer Institute [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 greater than 500 µmol/l or urine output less than 400 ml/day or requirement for dialysis)
- •Added 02/06/2016:
- •1. Documented diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for high-risk disease
- •2. Patient has active or prior hepatitis C
研究者
相似试验
已完成
不适用
sing dental ceramics in treating patients with worn teeth. A randomized clinical trial.Oral HealthTooth wearISRCTN16324420ational Dental Eastman Institute (Folktandvården Eastmaninstitutet)132
已完成
不适用
Point-of-care testing for gastrointestinal pathogensGastroenteritisISRCTN88918395niversity Hospital Southampton NHS Foundation Trust278
已完成
不适用
The child with atopic dermatitis/food allergy and his parents: from victim to expert in the multidisciplinary teamAtopic dermatitis (and food allergy within the atopic syndrome)Skin and Connective Tissue DiseasesAtopic dermatitisISRCTN08506572Foundation for Children's Welfare Stamps Netherlands (Stichting Kinderpostzegels Nederland) (Netherlands)140
已完成
不适用
The effect of a cognitive behavioural program called ?Michael?s Game? on psychotic symptomsPsychotic disordersMental and Behavioural DisordersISRCTN37178153Geneva University Hospitals (Switzerland)166
已完成
不适用
SWITCH - Sensing With Insulin pump Therapy to Control HbA1cNutritional, Metabolic, EndocrineType 1 diabetes mellitusISRCTN09806152Medtronic International Trading Sarl (Switzerland)160