A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
N/A
75 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Comparison of response rates
Safety Issue:
No
Principal Investigator
Gordon Cook, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Leeds Cancer Centre at St. James's University Hospital
Authority:
United States: Federal Government
Study ID:
WSLG-H31
NCT ID:
NCT00006232
Start Date:
October 1996
Completion Date:
August 2007
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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