EUCTR2010-018594-37-SE进行中（未招募）不适用
European Myeloma Network sequential phase I / phase II trial on RIC allogeneictransplantation: an optimized program for high risk relapsed patients - EMN-alloRI
European Myeloma Network0 个研究点目标入组 25 人开始时间: 2012年11月9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
- 25
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
- •Inclusion criteria for the phase II trial:
- •o High-risk multiple myeloma patients at first relapse / second complete remission candidates to receive an allogeneic transplantation
- •o Age: ³ 18 < 70 years.
- •o Suitable donor, related or unrelated (a maximum of 1 mismatched is allowed)
- •o Measurable disease
- •o High risk first relapse is defined as:
- •· First early relapse after ASCT (< 24 months)
- •· First late relapses in case the patient does not achieve CR after second ASCT
- •· First relapse in patients with poor cytogenetic features
- •o All subjects must be able to comply with the Lenalidomide Pregnancy Prevention
- •o Patient signs the study informed consent form
- •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 20
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Patient who is a known carrier of the human immunodeficiency virus (HIV), hepatitis B virus surface antigen or active infection by the hepatitis C virus (those in which the hepatitis C virus RNA can be detected).
- •- Patients who have experienced a myocardial infarction within 6 months prior to entry in the clinical trial or are in New York Heart Association (NYHA) functional class III or IV, heart failure, uncontrolled angina, uncontrolled ventricular arrhythmia or acute ischemia detected in the ECG, or conduction system abnormalities.
- •- Patients who are currently in another clinical trial or receiving any investigational agent
- •- Prior history of other malignant diseases other than myeloma (except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) unless the patient is disease-free longer than 5 years.
- •- Hypertension or poorly-controlled diabetes mellitus or any other serious organic disease involving an excessive risk to the patient or any psychiatric disorder that interferes with the understanding of the informed consent
- •o Prior severe comorbidity such as:
- •· Peripheral neuropathy ³ Grade 2 14 days prior to inclusion
- •· Psychiatric disease
- •· Hypersensitivity to Bz, Boric acid manitol.
- •· Patients unable to use appropriate contraceptive methods
- •· Patients who have received an investigational drug 30 days prior to inclusion
- •· Patients with pericardial disease
- •· Patients with acute diffuse infiltrative pulmonary
- •· Patients not willing to comply with the Lenalidomide Pregnancy Prevention Risk Management Plan
- •· Patients not willing to receive thromboprophylaxis during the consolidation phase will not be eligible.
研究者
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