EUCTR2010-021451-12-GB进行中（未招募）1 期
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma - MUK one
niversity of Leeds0 个研究点目标入组 95 人开始时间: 2010年10月8日最近更新:
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
- 95
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
- •Males and females, aged =18 years
- •Histologically confirmed multiple myeloma (MM) with measurable disease parameters requiring therapy for relapsed or refractory disease (first relapse or later)
- •Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use effective methods of contraception in accordance with (and consent to) the Celgene and Astellas SPC-approved process for thalidomide and bendamustine risk management and pregnancy prevention, or commit to absolute and continuous abstinence. Men must not father a child for up to 6 months following cessation of treatment
- •Performance Status (ECOG) 0-3
- •Life expectancy at least 3 months
- •Able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 49
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •Pregnant or lactating. Women of child bearing potential must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene-approved process for thalidomide risk management and pregnancy prevention.
- •Non-secretory MM
- •Relapsed on previous bendamustine therapy
- •Unsupported platelet count <75 x 10 9/L within 14 days before enrolment (unless attributable to the myeloma in the opinion of the local investigator).
- •Absolute neutrophil count <1.5 x10 9/L within 14 days before enrolment.
- •Serum bilirubin >2 times upper limit of normal within 14 days before enrolment
- •Serum ALT/AST >2.5 times upper limit of normal within 14 days before enrolment
- •Calculated or measured creatinine clearance <10 mL/minute within 14 days before enrolment
- •=Grade 2 (NCI criteria) peripheral neuropathy within 14 days before enrolment.
- •Any history of hypersensitivity to any of the study medications or excipients
- •Seropositive for HIV, or active hepatitis A, B or C infection
- •Concurrent or previous malignancies (<12 months post end of treatment) at other sites, with the exception of appropriately treated localised epithelial skin or cervical cancer. Patients with histories (.=12 months) of other tumours may be entered.
- •Evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator’s opinion, preclude entry into the study.
- •Poorly controlled hypertension or diabetes mellitus or other serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical study.
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis.
- •Received an investigational medicinal product within 28 days of study entry (randomisation or registration)
- •Major surgery less than 30 days before start of treatment
- •Yellow fever vaccination within 3 month before enrolment
研究者
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