Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria:

Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria:

* Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma

PLUS one or more of the following:

* Calcium elevation (11.5 mg/dl) \[42.65 mmol/l\]
* Renal insufficiency (1.5 x the ULN of serum creatinine)
* Anemia (hemoglobin \<=10 g/dl or 2 g/dl \<= normal)
* Bone disease (lytic lesions or osteopenia)

Measurable disease is defined at least one of the following three measurements:

* Serum M-protein \>=1 g/dl ( or 10 g/l)
* Urine M-protein \>=200 mg/24 h
* Serum FLC assay: Involved FLC level \>=10 mg/dl (\>=100 mg/l) provided serum FLC ratio is abnormal
* Measurable plasmacytoma
* NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response.

Laboratory test results within these ranges:

* Absolute neutrophil count \>= 1.0 x 109/L
* Platelet count \>= 50 x 10(9)/L
* Hemoglobin \>= 9 gm/dl
* Serum creatinine \<= 2.5mg/dL.
* Total bilirubin \<=1.5 x upper limit of normal
* AST (SGOT) and ALT (SGPT) \<= 3 x ULN

Exclusion Criteria:

* Known hypersensitivity to thalidomide
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Patients with a solitary plasmacytoma
* Patients with uncontrolled diabetes
* Patients with ≥ Grade 3 sensory neuropathy
* History of cardiac disease, with NYHA Class II or greater