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..
Patients with newly diagnosed, symptomatic multiple myeloma based on the following
- 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
- 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
- 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