EUCTR2009-012359-91-FR进行中（未招募）不适用
Multicenter Phase II Study of Bendamustine, Velcade (Bortezomib) and Dexamethasone (BVD) in the treatment of elderly patients (> or =65 years) with multiple myeloma in 1st relapse or refractory to 1st line therapy - BVD
Intergroupe Francophone du Myélome0 个研究点目标入组 70 人开始时间: 2009年8月5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
- 入组人数
- 70
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
- •Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not necessarily at the time of relapse)
- •Patient having received conventional chemotherapy in 1st line treatment because of age 65 years or over, or younger than 65 years and ineligible to high-dose therapy plus stem cell transplantation.
- •Measurable disease (>10g/L monoclonal gammapathy or > 200 mg/24h proteinuria)
- •Patient in 1st relapse or refractory to 1st line therapy.
- •Relapse is defined by M-component increase of =25% from baseline, in serum and/or urine (the absolute increase in serum must be = 5 g/l - the absolute increase of BJ proteins in urine must be =200 mg/24 h).
- •Life expectancy of at least 3 months
- •ECOG performance status < or = 2 at study entry
- •Laboratory test results within these ranges:
- •- Absolute neutrophil count >or= 1.5 x 109/L
- •- Platelet count >or= 100 x 109/L
- •- Serum creatinine - AST (SGOT) and ALT (SGPT) • Disease free of prior malignancies for >or= 5 years, with exception of curatively treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast
- •Able to adhere to the study visit schedule and other protocol requirements
- •Using effective contraceptive methods during and for 6 months after study treatment (for fertile men, women of childbearing potential).
- •Provision of 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
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Any comorbidity which places the subject at unacceptable risk if he/she were to participate in the study.
- •Patients treated with high-dose therapy plus stem cell transplantation in 1st line therapy
- •Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin)
- •Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan
- •Use of any other experimental drug or therapy within 28 days prior to the start of study treatment.
- •Known hypersensitivity to the study drugs
- •Positive HIV serology or infectious hepatitis type A, B or C.
- •Severe cardiovascular disorders within 12 months prior to the start of study treatment (e.g. myocardial infarct, ischemic episodes, arrhytmias)
- •Previous major surgery less than 30 days before start of treatment
- •Active infection,
- •Pregnant or lactating women.
研究者
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