NCT00832234已完成2 期
Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in Previously Untreated Patients With Waldenstroms Macroglobulinemia: A Multicenter Trial of the European Myeloma Network
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
研究概览
简要总结
This is a Phase II multicenter study designed to evaluate the safety and efficacy of combination BDR. BDR will be administered in one 21-day treatment cycle followed by four 35-day treatment cycles to patients with WM.
详细描述
Title: Phase II Study of Combination Bortezomib (VELCADE, PS-341), Dexamethasone, and Rituximab (MabThera) (BDR) in Patients with previously untreated Waldenstroms Macroglobulinemia (WM).
Objectives:
The primary objective of this study is:
- To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
Secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must meet all of the following inclusion criteria to be enrolled in this study:
- •Clinicopathological diagnosis of Waldenstroms macroglobulinemia as defined by consensus panel one of the Second International Workshop on Waldenstroms 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. In that case baseline monoclonal protein levels for assessment of response will be the levels prior to plasmapheresis, if this is the higher value prior to treatment initiation
- •Patients must have at least one of the following indications to initiate treatment as defined by Consensus Panel Two recommendations from the Second -
- •International Workshop on Waldenstroms Macroglobulinemia.
- •Recurrent fever, night sweats, weight loss, fatigue
- •Hyperviscosity
- •Lymphadenopathy which is either symptomatic or bulky (>5cm in maximum diameter)
- •Symptomatic hepatomegaly and/or splenomegaly
- •Symptomatic organomegaly and/or organ or tissue infiltration
- •Peripheral neuropathy due to WM
- •Symptomatic cryoglobulinemia
- •Cold agglutinin anemia
- •Immune hemolytic anemia and/or thrombocytopenia
- •Nephropathy related to WM
- •Amyloidosis related to WM
- •Hemoglobin < 10g/dL
- •Platelet count < 100x109/L
- •Serum monoclonal protein >5g/dL even with no symptoms
- •CD20 positive disease based on any previous bone marrow immunohistochemistry or flow cytometric analysis performed up to 3 months prior to enrollment.
- •Karnofsky performance status more than
- •Life-expectancy >3 months.
- •Baseline platelet count more than 50x109/L, and absolute neutrophil count more than 0.75x109/L.
- •Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
- •AST (SGOT): less than 3 times the upper limit of institutional laboratory normal.
- •ALT (SGPT): less than 3 times the upper limit of institutional laboratory normal.
- •Total Bilirubin: less than 2 times the upper limit of institutional laboratory normal, unless clearly related to the disease.
- •Calculated or measured creatinine clearance: less than 30 mL/minute. Serum sodium >130 mmol/L.
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- •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
- •Women who are pregnant.
- •Women who are breast-feeding and do not consent to discontinue breast-feeding.
- •Women of childbearing age who are not willing to use effective anti-conceptive methods for the duration of the study and 6 months thereafter.
- •Men who do not consent not to father a child during the treatment period and six months thereafter.
研究组 & 干预措施
BDR
Experimental
干预措施: Bortezomib, Dexamethasone, Rituximab (Drug)
结局指标
主要结局
The response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.
时间窗: Two years
次要结局
- Time to progression following treatment with BDR The safety and tolerability of BDR in patients with WM.(Two years)
研究者
Professor Hans Erik Johnsen
Sponsor Office Director, Professor
Stichting European Myeloma Network
研究点 (1)
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