Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Newly diagnosed symptomatic multiple myeloma confirmed by the following:
• •* Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
• •* Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
• •No smoldering myeloma or monoclonal gammopathy of undetermined significance
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Absolute neutrophil count greater than 1,000/mm\^3
• •Platelet count greater than 50,000/mm\^3
• •Hemoglobin greater than 7 g/dL
• •Hepatic:
• •Bilirubin no greater than 1.5 mg/dL
• •ALT and AST no greater than 2.5 times upper limit of normal
• •Renal:
• •Creatinine less than 3 mg/dL
• •Cardiovascular:
• •No prior or concurrent deep venous thrombosis
• •Other:
• •Prior malignancy allowed provided the following criteria are met:
• •* Received prior treatment with curative intent
• •* Free of disease for the time period appropriate for cure of the specific cancer
• •No grade 2 or greater peripheral neuropathy due to other medical conditions
• •No active infection
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior biologic therapy for multiple myeloma
• •No other concurrent biologic therapy for multiple myeloma
• •Chemotherapy:
• •No prior chemotherapy for multiple myeloma
• •No other concurrent chemotherapy for multiple myeloma
• •Endocrine therapy:
• •More than 6 months since prior systemic dexamethasone or glucocorticoids
• •No concurrent corticosteroids
• •Radiotherapy:
• •At least 4 weeks since prior palliative, localized radiotherapy
• •Concurrent palliative, localized radiotherapy allowed at the physician's discretion
• •Surgery:
• •Not specified
• •Other:
• •No prior systemic therapy for multiple myeloma, except bisphosphonates
• •No concurrent anticoagulant therapy for deep vein thrombosis
• •No concurrent barbiturates or alcohol (thalidomide arm)