S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
Multiple Myeloma, Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility 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
Sites / Locations
- William Beaumont Hospital - Royal Oak Campus
- Utah Cancer Specialists at UCS Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.