EUCTR2010-020072-33-IT进行中（未招募）不适用
Bendamustine, Bortezomib and Dexamethasone (BVD) in the treatment of relapsed or refractory Multiple Myeloma - BVD-CLEM 01-10
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI0 个研究点开始时间: 2010年12月14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
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
- •Age 18-85 years at the time of signing the informed consent form ? Life expectancy of at least 3 months ? Able to adhere to the study visit schedule and other protocol requirements ? Relapsed or refractory MM after autologous SCT or conventional chemotherapy ? No more than 4 prior therapeuric regimens for MM ? Measurable disease (>10g/L monoclonal gammopathy or > 200 mg/day proteinuria) ? All previous MM therapy, including radiation, cytostatic therapy and surgery, must have been terminated at least 4 weeks prior to treatment in this study, without corticosteroid therapy. ? Eastern Cooperative Oncology Group (ECOG) performance status of ? 2 at study entry ? Laboratory test results within these ranges: - Absolute neutrophil count ? 1.0 x 109/L - Platelet count ? 75 x 109/L - Creatinine clearance > 30 ml/h) - Total bilirubin ? 1.5 mg/dL - Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) ? 2 x ULN or ? 5 x ULN if hepatic lesions are present. ? Disease free of prior malignancies for ? 5 years with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast ? Fertile patients must use effective contraception during and for 6 months after study treatment ? Patients must sign on an Informed Consent Form
- •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
- •? Absence of the Informed Consent Form signed by the patient ? Pregnant or breast feeding females ? Serious concomitant systemic disorder which, in the Protocol: BVD-CLEM 01-10 Final Version n?2? 22 July 2010 3 opinion of the investigator, may compromise the safety of the patient or the patient’s ability to complete the study. ? Use of any other experimental drug or therapy within 28 days of baseline. ? Known hypersensitivity to the study drugs ? Received 4 or more prior therapeutic regimens for MM ? Any prior use of bendamustine ? Refractory to bortezomib or remission duration less than 6 months with prior therapy containing bortezomib ? Peripheral neuropathy = grade 2 ? Heart diseases grade III-IV NYHA ? Uncontrolled diabetes or glaucoma ? Prior allogeneic stem cell transplantation ? Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan ? Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type A, B or C.
研究者
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