IMWG uniform response criteria by response subcategory for multiple myeloma7
| CR* . | Stringent complete response (sCR)† . | VGPR* . | PR . | SD . | PD† . |
|---|---|---|---|---|---|
| Negative immunofixation of serum and urine, and | CR as defined, plus | Serum and urine M-component detectable by immunofixation but not on electrophoresis, or | ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 hours | Not meeting criteria for CR, VGPR, PR, or PD | Increase of 25% from lowest response value in any of the following: |
| Disappearance of any soft tissue plasmacytomas, and | Normal FLC ratio and | ≥ 90% reduction in serum M-component plus urine M-component < 100 mg/24 h | If the serum and urine M-protein are not measurable, a decrease ≥ 50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria | Serum M-component (absolute increase must be ≥ 0.5 g/dL), and/or | |
| < 5% PCs in bone marrow | Absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry | If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥ 50% reduction in bone marrow PCs is required in place of M-protein, provided baseline percentage was ≥ 30% | Urine M-component (absolute increase must be ≥ 200 mg/24 h), and/or | ||
| In addition to the above criteria, if present at baseline, ≥ 50% reduction in the size of soft tissue plasmacytomas is also required | Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL) | ||||
| Only in patients without measurable serum and urine M protein levels and without measurable disease by FLC levels, bone marrow PC percentage (absolute percentage must be ≥ 10%) | |||||
| Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas | |||||
| Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder |
| CR* . | Stringent complete response (sCR)† . | VGPR* . | PR . | SD . | PD† . |
|---|---|---|---|---|---|
| Negative immunofixation of serum and urine, and | CR as defined, plus | Serum and urine M-component detectable by immunofixation but not on electrophoresis, or | ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg/24 hours | Not meeting criteria for CR, VGPR, PR, or PD | Increase of 25% from lowest response value in any of the following: |
| Disappearance of any soft tissue plasmacytomas, and | Normal FLC ratio and | ≥ 90% reduction in serum M-component plus urine M-component < 100 mg/24 h | If the serum and urine M-protein are not measurable, a decrease ≥ 50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria | Serum M-component (absolute increase must be ≥ 0.5 g/dL), and/or | |
| < 5% PCs in bone marrow | Absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry | If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥ 50% reduction in bone marrow PCs is required in place of M-protein, provided baseline percentage was ≥ 30% | Urine M-component (absolute increase must be ≥ 200 mg/24 h), and/or | ||
| In addition to the above criteria, if present at baseline, ≥ 50% reduction in the size of soft tissue plasmacytomas is also required | Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL) | ||||
| Only in patients without measurable serum and urine M protein levels and without measurable disease by FLC levels, bone marrow PC percentage (absolute percentage must be ≥ 10%) | |||||
| Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas | |||||
| Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder |
Adapted from Durie et al7 and Kyle et al13 with permission. All response categories (CR, sCR, VGPR, PR, and PD) require 2 consecutive assessments made at any time before the institution of any new therapy; CR, sCR, VGPR, PR, and SD categories also require no known evidence of progressive or new bone lesions if radiographic studies were performed. VGPR and CR categories require serum and urine studies regardless of whether disease at baseline was measurable on serum, urine, both, or neither. Radiographic studies are not required to satisfy these response requirements. Bone marrow assessments need not be confirmed. For PD, serum M-component increases of more than or equal to 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL.
PCs indicate plasma cells.
Clarifications to IMWG criteria for coding CR and VGPR in patients in whom the only measurable disease is by serum FLC levels: CR in such patients indicates a normal FLC ratio of 0.26 to 1.65 in addition to CR criteria listed above. VGPR in such patients requires a > 90% decrease in the difference between involved and uninvolved FLC levels.
Clarifications to IMWG criteria for coding PD: Bone marrow criteria for PD are to be used only in patients without measurable disease by M protein and by FLC levels; “25% increase” refers to M protein, FLC, and bone marrow results, and does not refer to bone lesions, soft tissue plasmacytomas, or hypercalcemia and the “lowest response value” does not need to be a confirmed value.