EUCTR2006-007022-64-DK进行中（未招募）不适用
Phase II study of bortezomib-dexametason and high-dose melphalan in patients relapsing after high-dose melphalan with autologous stem cell support
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •·First relapse after ASCT
- •·Symptomatic myeloma diagnosis according to international criteria
- •·More than 2,0 x 106 CD34+ stem cells / kg bodyweight 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Allogeneic transplantation scheduled as a part of the treatment
- •·Expected survival of less than one month.
- •·Performance status (WHO) > 3
- •·Neuropathy > Grade 2(neurological symptoms interfering with ADL)
- •·Non-secreting myeloma
- •·Other concurrent disease making bortezomib treatment unsuitable
- •·Positive pregnancy test (only applicable for women with childbearing
- •·Has known or suspected hypersensitivity or intolerance to boron,
- •mannitol, or heparin, if an indwelling catheter is used
- •·Uncontrolled or severe cardiovascular disease including myocardial
- •infarction within 6 months of enrolment, New York Heart Association
- •(NYHA) Class III or IV heart failure (NYHA Classification of Cardiac
- •Disease), uncontrolled angina, clinically significant pericardial disease, or
- •cardiac amyloidosis
- •·History of hypotension or has decreased blood pressure (sitting systolic
- •blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure
- •[DBP] £60 mmHg)
- •·Serious medical or psychiatric illness likely to interfere with participation in
- •this clinical study
- •·Have received an experimental drug or used an experimental medical
- •device within 4 weeks prior to inclusion into the study
研究者
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