Combination Chemotherapy in Treating Patients With Stage II or Stage III 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.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma|
- Comparison of response rates [ Designated as safety issue: No ]
- Time to achieve a maximal response [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
|Study Start Date:||October 1996|
|Study Completion Date:||August 2007|
- 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.
|Birmingham Heartlands Hospital|
|Birmingham, England, United Kingdom, B9 5SS|
|Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Royal Liverpool and Broadgreen Hospitals NHS Trust|
|Liverpool, England, United Kingdom, L7 8XP|
|New Cross Hospital|
|Wolverhampton, England, United Kingdom, WV10 0QP|
|Centre for Cancer Research and Cell Biology at Belfast City Hospital|
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Vale Of Leven D G Hospital|
|Alexandria, Scotland, United Kingdom, G83 0UA|
|Dumfries Royal Infirmary|
|Dumfries, Scotland, United Kingdom, DG1 4AP|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Royal Infirmary - Castle|
|Glasgow, Scotland, United Kingdom, G4 0SF|
|West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Royal Alexandra Hospital|
|Paisley, Scotland, United Kingdom|
|Study Chair:||Gordon Cook, MD, PhD||Leeds Cancer Centre at St. James's University Hospital|