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Phase III Randomized Study of Induction Therapy Comprising Idarubicin and Dexamethasone vs Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Completed | 75 and under | WSLG-H31
EU-20032, ISRCTN65684689, NCT00006232 |
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.
Entry 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
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
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: 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
Expected Enrollment 200A total of 200 patients (100 per arm) will be accrued for this study within 2
years. Outcomes Primary Outcome(s)Comparison of response rates
Secondary Outcome(s)Time to achieve a maximal response
Duration of response
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.
Trial Contact Information
Trial Lead Organizations West of Scotland Lymphoma Group | | | | Gordon Cook, MD, PhD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Randomized Trial Comparing Z-Dex with VAD as Induction Therapy for Patients with Multiple Myeloma | | | Trial Start Date | | 1996-10-18 | | | Registered in ClinicalTrials.gov | | NCT00006232 | | | Date Submitted to PDQ | | 2000-06-23 | | | Information Last Verified | | 2007-03-27 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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