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

This is a phase II single institution trial in patients with newly diagnosed multiple
myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50
mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..

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