ISRCTN05622749已完成3 期
Randomised phase III trial for previously untreated multiple myeloma to evaluate two regimens of bortezomib based induction therapy and lenalidomide consolidation followed by lenalidomide maintenance treatment
niversity Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)0 个研究点目标入组 504 人开始时间: 2010年4月27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
- 504
研究概览
简要总结
- 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25787915 (added 29/01/2019) 2. 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32034285 (added 10/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Confirmed diagnosis of multiple myeloma requiring systemic therapy
- •2. Measurable disease
- •3. Aged 18 - 70 years inclusive, either sex
排除标准
- •1. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression
- •2. Severe cardiac dysfunction
- •3. Significant hepatic dysfunction
- •4. Patients known to be human immunodeficiency virus (HIV)-positive
- •5. Patients with active, uncontrolled infections
- •6. Patients with peripheral neuropathy or neuropathic pain, Common Toxicity Criteria (CTC) grade 2 or higher
- •7. Patients with a history of active malignancy during the past 5 years
- •8. Systemic amyloid light chain (AL) amyloidosis
- •9. Pregnancy and lactation
研究者
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