Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

Inclusion Criteria

• •Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
• •Bone marrow plasmacytosis with \> or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
• •Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or \> 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
• •Age \> or = 18 years.
• •Life expectancy of greater than 12 months.
• •Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%).
• •Adequate organ and marrow function as defined below:
• •* Hgb \> or = 9 g/dL
• •* Absolute Neutrophil Count \> or = 1,500/ ml
• •* Platelets \> or = 50,000/mm3
• •* Total Bilirubin \< or = 1.5 mg/dL
• •* Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) \< or = 2.5 X upper limit of normal (ULN)
• •* Creatinine \< 2.0 mg/dL
• •* Creatinine Clearance \> or = 50 ml/min
• •Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
• •Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• •Ability to understand and the willingness to sign a written informed consent document.
• •Subjects with a history of prior malignancy are eligible provided there is no active malignancy and a low expectation of recurrence within 6 months.
• •Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or alternative prophylaxis with either low molecular weight heparin or warfarin as recommended.
• •Eligible for transplant with an age up to and including 75 years.
• •Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated separately.
• •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-international units per millilitre (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence or 2 acceptable methods of birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom.