ISRCTN03381785已完成2 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)
niversity College London (UK)0 个研究点目标入组 153 人开始时间: 2011年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Previously untreated patients with symptomatic myelom
- •2. Patients suitable for high dose therapy and ASCT
- •3. = 18 years of age
- •4. Performance score (PS) of 0-3 (ECO.G). Measurable disease as defined by one of the following:
- •4.1. 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)
- •4.2. 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)
- •5. Adequate full blood count within 14 days before registration:
- •5.1. Platelet count =75x109/L
- •5.2. Absolute neutrophil count (ANC) =1x109/L
- •6. Adequate renal function within 14 days before registration:
- •6.1. Creatinine clearance >30ml/min
- •7. Adequate hepatobiliary function within 14 days before registration:
- •7.1. Total bilirubi<2 x upper limit of normal (ULN)
- •7.2. ALT/AST <2.5 x ULN
- •8. Adequate pulmonary function:
- •8.1. 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
- •9. Adequate cardiac function:
- •9.1. Left ventricular ejection fraction (LVEF) =40% by echocardiogram and ECG.
- •10. If female and of childbearing potential (WCBP), must have a negative pregnancy test (either serum or urine HCG)
- •11. Able to give informed consent
排除标准
- •1. Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
- •2. Pregnant or breast-feeding
- •3. Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment womnle of childbearing potential (WCBP) or male whose partner is WCBP
- •4. Known history of allergy contributable to compounds containing boron or mannitol
- •5. 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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