NCT00006232已完成3 期
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
West of Scotland Lymphoma Group23 个研究点 分布在 1 个国家目标入组 200 人开始时间: 1996年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 23
- 主要终点
- Comparison of response rates
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.
PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.
详细描述
OBJECTIVES:
- Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.
- Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
- Compare the quality of life of patients treated with these 2 regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.
- Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.
Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage II or III multiple myeloma
- •No prior therapy except local radiotherapy to bone lesions
- •No indolent multiple myeloma
- •No monoclonal gammopathy of unknown significance
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2.34 mg/dL
- •No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
- •No requirement for dialysis
- •No other medical condition that would preclude intensive treatment
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Comparison of response rates
次要结局
- Time to achieve a maximal response
- Duration of response
研究者
研究点 (23)
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