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

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

The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in 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