Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 18 and over | NCI | RPCI-RP-0215 NCT00054158 |
Objectives
- Determine the overall response rate in patients with newly diagnosed stage I, II, or III multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide.
- Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen.
Entry Criteria
Disease Characteristics:
- Newly diagnosed stage I, II, or III multiple myeloma (MM)
- No refractory or relapsed MM
Prior/Concurrent Therapy:
Biologic therapy
- No prior thalidomide
Chemotherapy
- No more than 1 course of prior vincristine, doxorubicin, and dexamethasone
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent alcohol consumption
Patient Characteristics:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST less than 2.5 times upper limit of normal
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
- No active serious infections uncontrolled by antibiotics
- No insufficient mental capacity that would preclude informed consent
- No other medical condition or reason that would preclude study participation
- Willing and able to comply with the FDA-mandated S.T.E.P.S program
Expected Enrollment
Approximately 17-37 patients will be accrued for this study.
Outline
This is an open-label, nonrandomized study.
Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients also receive low-dose oral thalidomide daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression.
Patients are followed until disease progression or bone marrow transplantation.
Trial Lead Organizations
Roswell Park Cancer Institute
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| Asher Chanan-Khan, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients with Multiple Myeloma (MM) | |
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| Trial Start Date | 2004-08-31 | |
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| Registered in ClinicalTrials.gov | NCT00054158 | |
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| Date Submitted to PDQ | 2002-12-17 | |
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| Information Last Verified | 2006-04-01 | |
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| NCI Grant/Contract Number | CA16056 | |
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.
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