EUCTR2013-003789-15-DK进行中（未招募）1 期
Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell support
ordic Myeloma Study Group0 个研究点目标入组 200 人开始时间: 2013年12月18日最近更新:
适应症
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
- 200
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
- •Myeloma diagnosis according to IMWG criteria
- •First treatment demanding relapse after HDT according to IMWG criteria
- •More than 2.0 x 106 CD34+ stem cells / kg body weight in the freezer for stem cell support
- •Signed informed consent given prior to any study related activities have been performed
- •Age > 18 years
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Demographic
- •Allogeneic transplantation scheduled as a part of the treatment
- •Treatment demanding relapse less than one year after HDT
- •Myeloma treatment after the first HDT, except radiotherapy, bisphosphonates, denosumab and corticosteroids less than 6 days for symptom control
- •Patients not having received HDT as first line treatment
- •Previous treatment with carfilzomib
- •Expected survival of less than six months
- •Performance status (WHO) = 3
- •Serum M-component < 5 g/l and urine M-component < 200 mg/l
- •Any of the following laboratory abnormalities:
- •oAbsolute neutrophil count (ANC) < 1.0 × 109/L
- •oHemoglobin < 5 mmol/L (<80 g/L) (prior RBC transfusion or recom-binant human erythropoietin use is permitted)
- •oPlatelet count < 50 × 109/L (< 30 × 109/L if myeloma involvement in the bone marrow is > 50%)
- •oSerum ALT or AST > 3.5 times the upper limit of normal and serum direct bilirubin > 34 µmol/L (2 mg/dL)
- •oCreatinine clearance (CrCl) < 15 mL/minute, either measured or cal-culated using a standard formula
- •Concurrent conditions
- •Concurrent disease making treatment with carfilzomib, cyclophosphamide or dexamethasone unsuitable
- •Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to enrolment
- •Major surgery within 21 days prior to enrolment
- •Acute active infection requiring treatment
- •Known or suspected hypersensitivity or intolerance to melphalan, dexa-methasone or Captisol® (a cyclodextrin derivative)
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, NYHA Class III or IV heart failure, uncon-trolled angina, clinically significant pericardial disease, uncontrolled severe arrhytmias, or cardiac amyloidosis
- •LVEF <40%, determined by 2-D transthoracic echocardiogram (ECHO) or Multigated Acquisition Scan (MUGA)
- •Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment
- •Serious hepatic disorder, including active hepatitis B or C infection
- •Other serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Use of any investigational agents or experimental medical device within 28 days prior to enrolment into the study
- •Ethical/other
- •Pregnant or lactating females
- •Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
- •Male subjects must agree to practice contraception
研究者
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尚未招募
Unknown
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