Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
NCT ID: NCT00006232
Last Updated: 2013-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
1996-10-31
2007-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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dexamethasone
doxorubicin hydrochloride
idarubicin
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
ALL
No
Sponsors
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West of Scotland Lymphoma Group
OTHER
Principal Investigators
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Gordon Cook, MD, PhD
Role: STUDY_CHAIR
Leeds Cancer Centre at St. James's University Hospital
Locations
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Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals NHS Trust
Liverpool, England, United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Vale Of Leven D G Hospital
Alexandria, Scotland, United Kingdom
Dumfries Royal Infirmary
Dumfries, Scotland, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000068156
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20032
Identifier Type: -
Identifier Source: secondary_id
ISRCTN65684689
Identifier Type: -
Identifier Source: secondary_id
WSLG-H31
Identifier Type: -
Identifier Source: org_study_id
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