Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed multiple myeloma as evidenced by one of the following:
• •* Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
• •* Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis
• •* Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below
• •Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR
• •Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis
• •Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m\^2) within the past 60-100 days
• •* Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma
• •* No evidence of disease progression
• •PATIENT CHARACTERISTICS:
• •Age
• •16 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 6 months
• •Hematopoietic
• •No prior hereditary hypercoaguable disorder
• •Granulocyte count at least 1,000/mm\^3
• •Platelet count at least 75,000/mm\^3
• •Hepatic
• •Bilirubin no greater than 2 times upper limit of normal (ULN)
• •AST and/or ALT no greater than 2 times ULN
• •Alkaline phosphatase no greater than 2 times ULN
• •Renal
• •Creatinine no greater than 3 times ULN
• •Cardiovascular
• •No prior spontaneous deep vein thrombosis within the past 5 years
• •* Catheter-associated thrombus allowed
• •No uncontrolled hypertension
• •Pulmonary
• •No prior pulmonary embolism within the past 5 years
• •Other
• •No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured
• •No prior gastric ulceration or bleeding within the past 5 years
• •No prior documented lupus anti-coagulant or anti-phospholipid antibody
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation
• •Male patients must use effective barrier contraception during and for 1 month after study participation
• •No avascular necrosis of the hips or shoulders
• •No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed)
• •No diabetes with end-organ damage defined as:
• •* Documented diabetic neuropathy
• •* Retinal vascular proliferation requiring treatment
• •* Cardiovascular disease requiring active therapy
• •Willing to complete quality of life questionnaires
• •Employment does not prohibit the use of sedatives
• •No other major medical illness or condition that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •See Disease Characteristics
• •No prior double autologous or allogeneic hematopoietic stem cell transplantation
• •No prior thalidomide
• •Chemotherapy
• •See Disease Characteristics
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •Not specified
• •Surgery
• •Not specified
• •Other
• •No other concurrent anti-cancer therapy
• •No other concurrent investigational therapy