EUCTR2010-021598-35-GB进行中（未招募）1 期
Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT (PADIMAC) - PADIMAC
niversity College London0 个研究点目标入组 120 人开始时间: 2010年7月29日最近更新:
适应症
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
- 120
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
入选标准
- •i. Previously untreated patients with symptomatic myeloma ii. Patients suitable for high dose therapy and ASCT iii. = 18 years of age iv. Performance score (PS) of 0-3 (ECOG) v. Measurable disease as defined by one of the following: a. Secretory myeloma: Monoclonal protein in the serum or monoclonal light chain in the urine (Bence Jones protein =200mg/24hours), or serum free light chain (SFLC, involved light chain =100mg/L provided the FLC ratio is abnormal) b. Non-secretory myeloma: =30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacytoma =2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan) vi. Adequate full blood count within 14 days before registration: a. Platelet count =75x109/L b. Absolute neutrophil count (ANC) =1x109/L vii. Adequate renal function within 14 days before registration: a. Creatinine clearance >30ml/min viii. Adequate hepatobiliary function within 14 days before registration: a. Total bilirubin <2 x upper limit of normal (ULN) b. ALT/AST <2.5 x ULN ix. Adequate pulmonary function: a. No evidence of a history of infiltrative pulmonary disease. If a history, then KCO/DLCO (Carbon Monoxide diffusion in the lung) =50% and/or no requirement for supplementary continuous O2 x. Adequate cardiac function: a. Left ventricular ejection fraction (LVEF) =40% by Echocardiogram and ECG. xi. If female and of childbearing potential (WCBP), must have a negative pregnancy test (either serum or urine HCG) xii. Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •i. Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) ii. Pregnant or breast-feeding iii. Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential(WCBP), or male whose partner is WCBP iv. Known history of allergy contributable to compounds containing boron or mannitol v. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient’s participation in this study
研究者
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Phase II study of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCTTopic: National Cancer Research NetworkSubtopic: Haematological OncologyDisease: MyelomaCancerMultiple myelomaISRCTN03381785niversity College London (UK)153
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