Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
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.
研究概览
详细说明
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.
Quality of life is assessed at baseline and then prior to each study course.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
England
-
Birmingham、England、英国、B9 5SS
- Birmingham Heartlands Hospital
-
Cambridge、England、英国、CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
-
Liverpool、England、英国、L7 8XP
- Royal Liverpool and Broadgreen Hospitals NHS Trust
-
Wolverhampton、England、英国、WV10 0QP
- New Cross Hospital
-
-
Northern Ireland
-
Belfast、Northern Ireland、英国、BT9 7AB
- Centre for Cancer Research and Cell Biology at Belfast City Hospital
-
-
Scotland
-
Aberdeen、Scotland、英国、AB25 2ZN
- Aberdeen Royal Infirmary
-
Alexandria、Scotland、英国、G83 0UA
- Vale Of Leven D G Hospital
-
Dumfries、Scotland、英国、DG1 4AP
- Dumfries Royal Infirmary
-
Dundee、Scotland、英国、DD1 9SY
- Ninewells Hospital and Medical School
-
Glasgow、Scotland、英国、G4 0SF
- Royal Infirmary - Castle
-
Glasgow、Scotland、英国、G11 6NT
- West of Scotland Cancer Centre
-
Paisley、Scotland、英国
- Royal Alexandra Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age:
- 75 and under
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.34 mg/dL
Renal:
- No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
- No requirement for dialysis
Other:
- 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
Surgery
- See Disease Characteristics
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
Comparison of response rates
|
次要结果测量
结果测量 |
|---|
|
反应持续时间
|
|
Time to achieve a maximal response
|
合作者和调查者
调查人员
- 学习椅：Gordon Cook, MD, PhD、Leeds Cancer Centre at St. James's University Hospital
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- WSLG-H31
- CDR0000068156 (注册表标识符：PDQ (Physician Data Query))
- EU-20032
- ISRCTN65684689
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.