Multiple Myeloma Clinical Trial
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III multiple myeloma.
Full Description
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.
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.
PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed stage I, II, or III multiple myeloma (MM)
No refractory or relapsed MM
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
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
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There is 1 Location for this study
Buffalo New York, 14263, United States
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