NL-OMON30654招募中2 期
Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom*s Macroglobulinemia: A multicenter Trial of the European Myeloma Network - Combination BDR in Waldenstrom*s Macroglobulinemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Clinicopathological diagnosis of Waldenstrom*s macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstrom*s macroglobulinemia. All patients with the diagnosis of WM will be evaluable for response according to the response criteria.
- •No prior systemic treatment for WM. Prior plasmapheresis to control hyperviscosity, is allowed.
排除标准
- •Prior systemic treatment with WM (plasmapheresis is allowed)
- •Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- •Patient has hypersensitivity to dexamethasone, bortezomib, boron or mannitol.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Cardiac amyloidosis.
- •Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3.
研究者
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