NCT00319865Unknown2 期
PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma
Korean Multiple Myeloma Working Party1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Response rate of PAD induction Therapy
研究概览
简要总结
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
详细描述
Although the overall survival was improved with the introduction of high dose therapy with autologous hematopoetic stem cell transplantation,it remains as a incurable disease. Most patients ultimately relapse. Recenlty, targeted therapy using novel agents, such as bortezomib and thalidomide, shows the possibility of improved in this situation. Among them, PAD (Velcade, Adriamycin,Dexamethasone) showed highest response rate. PAD does not show any cross resiatance with another effective combination, thalidomide plus dexamethasone.
We desined prospective multicenter phase 2 study using these combination sequentially.
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
- 0 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy.
- •* Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day
- •* Age \< 75
- •* Performance status \ 6 months
- •* who signs the informed consent
排除标准
- •known hypersensitivity to thalidomide or dexamethasone
- •known refractoriness to thalidomide + dexamethasone
- •Previous Velcade therapy
- •Woman in reproductive age
- •Serum creatinine > 2 mg/dL ; 24 hour creatinine clearance < 30 ml/min; past medical history of kidney transplatation
- •Peripheral neuropathy >/= grade 2
- •Recurrent DVT or pulmonary embolism
- •Cardiac ejection fraction <0.5 : Severe conduction disorder
- •Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis
- •Active ulcers in gastrofiberscope
结局指标
主要结局
Response rate of PAD induction Therapy
次要结局
- Response rate of PAD followed by Thal/Dex maintenance
- Progression free survival and Overall survival of PAD/Thal-Dex.
- To evaluate toxicities of PAD/Thal-Dex
研究者
研究点 (1)
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