EUCTR2017-004592-31-ES进行中（未招募）1 期
Venous Thromboembolism Prophylaxis with Apixaban in Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Receiving Induction Therapy with an Immunomodulatory-Based Regimen
Health Research Institute Hospital La Fe0 个研究点目标入组 60 人开始时间: 2018年4月4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
- 60
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
- •Signed written informed consent:
- •Each subject, or their legally acceptable representative, must sign an informed consent form indicating that he or she understands the purpose and procedures required for the study, and are willing to participate in the study. Consent to participate in the study will be obtained prior to screening.
- •Target population:
- •Subjects must have documented newly diagnosed symptomatic multiple myeloma requiring front-line treatment.
- •Patients should be considered transplant-eligible.
- •Subjects will receive front-line induction therapy with a triplet regimen consisting of bortezomib, thalidomide and dexamethasone (VTD).
- •To enter to the study at the same time of start anti myeloma induction therapy.
- •Patient features:
- •Ages eligible for study: 18 to 70 years.
- •Genders eligible for study: both.
- •Race eligible for study: any.
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score =2.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Target population exceptions:
- •Patients with the diagnosis of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome or amyloidosis of light chain.
- •Patients with smouldering multiple myeloma or monoclonal gammopathy of undeterminated significance.
- •Patients considered non-transplant-eligible.
- •Medical history and concurrent diseases:
- •Grade =2 of peripheral neuropathy.
- •Prior history of documented any venous thromboembolism and arterial thrombosis event.
- •Active or high risk of bleeding.
- •Need for on-going anticoagulant or antiplatelet treatment.
- •Contraindication of anticoagulant prophylaxis.
- •Uncontrolled hypertension: systolic blood pressure >200 mmHg and/or diastolic blood pressure >100 mmHg.
- •HIV, HBV or HCV-positive active.
- •Expected survival <6 months.
- •Weight <40 Kg.
- •Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin, or other oral anticoagulants.
- •Laboratory test findings:
- •Low platelet count (<50 x109/L).
- •ALT >3x UNL, bilirubin >2x ULN.
- •Creatinine clearance <30 mL/min.
- •Sex and reproductive status:
- •Women of childbearing potential who are unwilling to use an acceptable method of contraception.
- •Women of childbearing potential who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment, prior to investigational product administration.
- •Other exclusion criteria:
- •Administration of any investigational drug currently or within 30 days prior to planned enrollment into this study.
- •Subjects unwilling or unable to comply with study medication instructions or study procedures (e.g. bilateral lower extremity venous ultrasonography).
- •Known allergies to ingredients contained in apixaban.
- •Use of any contraindicated medications with apixaban (see section 5.4.1).
研究者
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