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

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)