S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Previously untreated multiple myeloma
• •* Stage I, II, or III disease by the International Staging System
• •Measurable M-protein as defined by 1 of the following:
• •* Serum M-protein at least 1.0 g/dL by serum protein electrophoresis or immunoelectrophoresis
• •* Urinary M-protein excretion at least 200 mg/24 hours
• •No nonsecretory multiple myeloma
• •Not planning to undergo future autologous stem cell transplantation
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Zubrod 0-3\* NOTE: \*Zubrod 3 allowed only if multiple myeloma is the central cause of disability
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Platelet count at least 80,000/mm\^3\*
• •Absolute neutrophil count at least 1,000/mm\^3\*
• •Hemoglobin at least 9 g/dL\* (epoetin alfa or transfusion allowed) NOTE: \*Unless due to greater than 50% marrow involvement by myeloma on biopsy
• •Hepatic
• •AST/ALT no greater than 3 times upper limit of normal\* NOTE: \*Values outside of this range are allowed at the investigator's discretion
• •Renal
• •Creatinine no greater than 2.5 mg/dL\* NOTE: \*Values outside of this range are allowed at the investigator's discretion
• •Cardiovascular
• •No New York Heart Association class III or IV heart failure
• •No myocardial infarction within the past 6 months
• •No poorly controlled hypertension
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
• •* Female patients must use 2 reliable forms of contraception simultaneously
• •* Male patients must use effective barrier contraception
• •No uncontrolled active infection requiring IV antibiotics
• •No poorly controlled diabetes mellitus that would preclude ability to take oral glucocorticoids
• •No other serious medical condition that would preclude study participation
• •No psychiatric illness that would preclude study participation
• •No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• •Must be able to take aspirin by mouth at a dose of 325 mg per day or enoxaparin subcutaneously at a dose of 40 mg per day as a form of thrombotic prophylaxis, except if already on therapeutic anticoagulant medication
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior interferon or thalidomide
• •Chemotherapy
• •No prior chemotherapy
• •Endocrine therapy
• •Prior high-dose dexamethasone allowed provided duration of administration was no more than 4 days
• •Radiotherapy
• •Prior localized radiotherapy allowed provided it was not to the sole site of evaluable disease
• •Surgery
• •Not specified
• •Other
• •No prior treatment for clinically significant ventricular cardiac arrhythmias
• •Concurrent bisphosphonates allowed