MedGen

Any one or more of the following criteria: increase of 25 percent from lowest confirmed response value in one or more of the following criteria: serum M-protein (absolute increase must be at least 0.5 g/dL); serum M-protein increase at least 1 g/dL, if the lowest M component was at least 5 g/dL; urine M-protein (absolute increase must be at least 200 mg/24 h); in patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain levels (absolute increase must be greater than 10 mg/dL); in patients without measurable serum and urine M-protein levels and without measurable involved free light chain levels, bone marrow plasma-cell percentage irrespective of baseline status (absolute increase must be at least 10 percent); appearance of a new lesion(s), at least 50 percent increase from nadir in sum of products of diameters of greater than 1 lesion, or at least 50 percent increase in the longest diameter of a previous lesion greater than 1 cm in short axis; at least 50 percent increase in circulating plasma cells (minimum of 200 cells per uL) if this is the only measure of disease. [from NCI]

Multiple myeloma with all of the following: 1. Hemoglobin greater than 10 g/Dl, 2. Normal serum calcium, 3. Normal bone structure, 4. Low monoclonal (or myeloma) protein (M protein) production as shown by: a. IgG less than 5.0 g/dL, b. IgA less than 3.0 g/dL, c. Urinary kappa or lamda less than 4 g/24 hours. Estimated myeloma cell mass: less than 0.6 trillion (1012)/m2 (low burden). The following subclassification of stages is used: a. Creatinine less than 2.0 mg/dL, b. Creatinine greater than or equal to 2.0 mg/dL. Impaired renal function worsens prognosis regardless of stage. Note that the newer International Staging System defines stage I quite differently: Beta-2-microglobulin less than 3.5 and albumin greater than or equal to 3.5 (median survival of 62 months). (PDQ) [from NCI]

Multiple myeloma with one or more of the following: 1. Hemoglobin less than 8.5 g/dL. 2. Serum calcium greater than 12.0 mg/dL. 3. More than three lytic bone lesions. 4. High M protein production as shown by: a. IgG greater than 7.0 g/dL. b. IgA greater than 5.0 g/dL. c. Urinary kappa or lamda greater than 12.0 g/24 hours. Estimated myeloma cell mass: greater than 1.2 trillion (1012)/m2 (high burden). The following subclassification of stages is used: a. Creatinine less than 2.0 mg/dL. b. Creatinine greater than or equal to 2.0 mg/dL. Serum beta-2-microglobulin has been shown to be a reliable marker for prognosis. Since the great majority of symptomatic myeloma patients are classified as stage III by the Durie/Salmon criteria, this staging system has not proven to be very useful for identifying the patients with intermediate and poor prognosis. Note that the newer International Staging System defines stage III quite differently: Beta-2-microglobulin greater than or equal to 5.5 (median survival of 29 months). (PDQ) [from NCI]