NCT00205751已完成2 期
International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma
Austrian Forum Against Cancer2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2001年8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
- 350
- 试验地点
- 2
- 主要终点
- Time to progression
研究概览
简要总结
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
- •WHO performance status 0,1,2,or 3
- •No prior treatment of multiple myeloma
- •Clear requirement of treatment (usually Durie/Salmon stage II or III)
- •Anticipated life expectancy of at least 3 months
- •Adequate organ function
- •Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
- •Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
- •Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent
排除标准
- •Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
- •Benign monoclonal gammopathy
- •Multiple myeloma of IgM without osteolytic bone lesions
- •Smouldering myeloma
- •More than 3 irradiation fields
- •Irreversible performance status of WHO4
- •Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
- •Women of childbearing potential
- •Preexisting peripheral polyneuropathy
- •Congestive heart failure NYHA III, IV
- •Acute infection requiring systemic antibiotics at study entry until resolved
- •Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
- •Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
结局指标
主要结局
Time to progression
Response rate
次要结局
- Toxicity
- Survival
- Time to response
- Quality of life
研究者
研究点 (2)
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