A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In 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)