NCT00320476已完成2 期
Velcade®, Thalidomide, Dexamethasone (VTD) Induction Therapy Followed By Melphalan, Prednisone, Thalidomide (MPT) Maintenance As a First Line Treatment For The Patients With Multiple Myeloma Who Are Non-Transplant Candidates
Korean Multiple Myeloma Working Party2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Response rate of VTD induction Therapy
研究概览
简要总结
Multiple Myeloma is a incurable disease. Recently developed targeted therapy gave new hope for the patients with multiple myeloma. Velcade in combination with other agents are currently in trials for the newly diagnosed patient, we designed sequential treatment with VTD and MPT for the patients who are not transplant candidates. This would be expected to result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high dose therapy with autologous transplantation in younger population
详细描述
The two effective and non-cross resistant regimens, VTD and MPT, will be applied sequentially to the patients with multiple myeloma who are not transplant candidates. This would be expected to result in maximal tumor control, and thus, in maximal survival benefit, equivalent to high dose therapy with autologous transplantation in younger population
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with overt multiple myeloma who are not candidates for HDT/SCT because of old age (> 65) or presence of comorbid conditions likely to have a negative impact on tolerability of HDT/SCT. Sponsors review this conditions and approval is required.
- •Presence of measurable disease : serum M-protein > 1g/dL or urine M- protein > 400mg/day
- •Performance status £ ECOG 2
- •Expected survival ³ 6 months
- •Pretreatment clinical laboratory values meeting the following criteria within 14 days before enrollment platelet ≥ 100 x 109/L hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L) Prior RBC transfusion or recombinant human erythropoietin use is allowed) absolute neutrophil count (ANC) ≥ 1.0 x 109/L aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal total bilirubin ≤ 1.5 times the upper limit of normal serum creatinine ≤ 3mg/dL corrected serum calcium <14 mg/dL (<3.5 mmol/L)
- •Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
排除标准
- •Smoldering or indolent myeloma
- •History of allergic reaction attributable to compounds containing boron or mannitol
- •Known hypersensitivity to thalidomide or dexamethasone
- •Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
- •Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, cardiac ejection fraction <0.5 : Severe conduction disorder : Hypotension (sitting systolic BP ≤ 100 mmHg and/or sitting diastolic BP ≤ 60 mmHg
- •Pregnancy or breastfeeding
- •Uncontrolled Diabetes Mellitus
- •Recurrent DVT or pulmonary embolism
- •Active ulcers detected by gastroscopy
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Receipt of extensive radiation therapy within 4 weeks
结局指标
主要结局
Response rate of VTD induction Therapy
时间窗: 2008-02-01
次要结局
- Response rate of VTD/MPT maintenance therapy(2008-02-01)
- Progression free survival Overall survival of VTD/MPT(2008-02-01)
- To evaluate toxicities of VTD/MPT(2008-02-01)
研究者
研究点 (2)
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