a Clonal bone marrow plasma cells >10% b Presence of serum and/or urinary M-protein (If no monoclonal protein is detected (non-secretory disease), then >/= 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.) c Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following: (i) Hypercalcemia: serum calcium >11.5 mg/100 mL (ii) Renal insufficiency: serum creatinine >2 mg/dL (iii) Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL (iv)Bone lesions: lytic lesions, severe osteopenia, or pathologic fracture.