Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma
Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma
The study is being done to compare the combination of lenalidomide and dexamethasone followed
 by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and
 dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will
 include how the subjects respond to each study treatment combination, and what side effects
 are caused by each combination.
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000
 deaths each year in the United States. Approximately one third of myeloma patients develop
 hypercalcemia and about two thirds present with anemia. As the second most common hematologic
 malignancy, myeloma remains incurable. In the last forty years, options for therapy have
 included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with
 those regimens continues to be inevitable with a median survival of 3 years.
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.