EUCTR2012-001320-36-GB进行中（未招募）1 期
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma. - MUK five
niversity of Leeds0 个研究点目标入组 300 人开始时间: 2012年6月20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
- 300
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
- •Syptomatic multiple myeloma and requiring therapy for first relapse or primary refractory disease
- •Measurable disease
- •Age = 18 years
- •Life expectancy = 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status 0–2
- •Adequate hepatic function, with serum ALT = 3.5 times the upper limit of normal and serum direct bilirubin = 2 mg/dL (34 µmol/L) within 14 days prior to randomisation
- •Absolute neutrophil count (ANC) = 1.0 × 10^9/L within 14 days prior to randomisation (growth factor support is not permitted). ANC = 0.8 × 109/L is allowed for participaents with racial neutropenia provided the following conditions are met:
- •i)participant is considered to have racial neutropenia (i.e. is of African or African-Caribbean descent with ANC = 0.8 × 109/L
- •ii)trial entry has been discussed directly with, and approved by, the CI
- •Haemoglobin = 8 g/dL (80 g/L) within 14 days prior to randomisation (participants may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines)
- •Platelet count = 75 × 10^9/L (= 50 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to randomisation. Platelet support is not permitted.
- •Creatinine clearance (CrCl) = 15 mL/minute within 14 days prior to randomisation, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- •Written informed consent
- •Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception.
- •Male participants must agree to practice contraception
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Non-secretory multiple myeloma
- •Extramedullary plasmacytoma (without evidence of myeloma)
- •Received therapy for their first relapsed or primary refractory disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone up to a maximum of 200mg.
- •Previous bortezomib therapy is permitted, providing participant was not refractory (achieved at least a PR, and no disease progression within 6 months of last dose of bortezomib)
- •Previous carfilzomib therapy
- •Pregnant or lactating females
- •Major surgery within 21 days prior to randomisation
- •Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomisation
- •Known human immunodeficiency virus infection
- •Active hepatitis B or C infection
- •Unstable angina or myocardial infarction within 6 months prior to randomisation, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless participant has a pacemaker, history of torsade de pointe, QTc prolongation (> 450 msec), LVEF < 40
- •Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomisation
- •Previous or concurrent active malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localised transitional cell carcinoma of the bladder or benign tumours of the adrenal or pancreas
- •Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to randomisation
- •Patients with haemorrhagic cystitis
- •Known history of hypersensitivity to any of the study medications or excipients
- •Participants undergoing active treatment for infiltrative lung disease
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment
- •Contraindication to IV hydration programme
- •Participants with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomisation
- •Any other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a participant’s ability to give informed consent
研究者
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