Response criteria for plasma cell leukemia

Category	Bone marrow criteria*	Peripheral blood criteria*	Serological criteria^¶	Other criteria
Stringent complete remission	Bone marrow plasma cells <5 percent and No malignant plasma cell by flow cytometry	No plasma cells in peripheral blood by flow cytometry	Negative serum and urine immunofixation Normal serum FLC ratio	Absence of extramedullary disease
Complete remission	Bone marrow plasma cells <5 percent	No plasma cells in peripheral blood	Negative serum and urine immunofixation^Δ	Absence of extramedullary disease
Very good partial response	Bone marrow plasma cells <5 percent	No plasma cells in peripheral blood	≥90 percent reduction of serum M-protein and 24-hour urinary M-protein <100 mg per 24 hours^◊	Absence of extramedullary disease
Partial response	Bone marrow plasma cells 5 to 25 percent	Peripheral blood plasma cells from 1 to 5 percent	≥50 percent reduction of serum M-protein and Reduction in 24-hour urinary M-protein by ≥90 percent and <200 mg per 24 hours^§	≥50 percent reduction in the size of extramedullary disease
Stable disease	Not meeting the criteria of either partial response or progressive disease
Progressive disease	>25 percent increase in plasma cells in a bone marrow aspirate or absolute increase ≥10 percent	>5 percent absolute increase in peripheral blood plasma cells	>25 percent increase in the level of the serum monoclonal paraprotein with an absolute increase ≥5 g/L >25 percent increase in the 24-hour urinary light chain excretion with an absolute increase ≥200 mg/24 hours	Hypercalcemia Definite increase in lytic bone lesions Definite increase in the size or number of extramedullary disease
Relapse from complete remission	More than 10 percent increase in bone marrow plasma cells	Reappearance of peripheral blood plasma cells at any level	Reappearance of original M-protein in serum and/or urine immunofixation	Any extramedullary disease

FLC: free light chain.
* It is recommended that at least 200 leukocytes on blood smears and 500 nucleated cells on marrow smears be counted.
¶ It should be maintained for a minimum of six weeks. In case of discrepancy or undetectable serological parameter, the patient must be classified according to bone marrow criteria.
Δ If the serum and urine M-protein are unmeasurable, a normal serum kappa/lambda FLC ratio is also required.
◊ If the serum and urine M-protein are unmeasurable, a ≥90 percent decrease in the difference between involved and uninvolved FLC levels is required instead of the M-protein.
§ If the serum and urine M-protein are unmeasurable, a ≥50 percent decrease in the difference between involved and uninvolved FLC levels is required instead of the M-protein.

Reprinted by permission from: Macmillan Publishers Ltd: Leukemia. Fernández de Larrea C, Kyle RA, Durie BM, et al. Plasma cell leukemia: consensus statement on diagnostic requirements, response criteria and treatment recommendations by the International Myeloma Working Group. Leukemia 2013; 27:780. www.nature.com/leu. Copyright © 2013.

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Response criteria for plasma cell leukemia