Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
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.
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.
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