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.

Exclusion Criteria:

• Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
• Receiving any other investigational agents or therapy within 28 days of baseline.
• Brain metastases.
• Subjects who are pregnant or breast feeding.
• History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).

• If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:

  • Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
  • Must not have thrombocytopenia requiring transfusion.
  • Must have a platelet count > 50,000.
  • Must have stable INR between 2-3.
• Smoldering myeloma or monoclonal gammopathy of undetermined significance.
• Active, uncontrolled infection.
• Active, uncontrolled seizure disorder (seizures in the last 6 months).
• Concurrent use of other anti-cancer agents or treatments.
• Positive for HIV or infectious hepatitis, type B or C.
• Hypersensitivity to thalidomide.
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk.