Complete response (CR) |
Negative immunofixation in the serum or urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells on bone marrow aspirate |
Stringent Complete Response (sCR) |
Complete response as defined above plus a normal serum free light chain ratio (FLC) and absence of clonal plasma cells on bone marrow aspirate |
Very Good Partial Response (VGPR) |
Serum and urine M-protein detectable on immunofixation but not on electrophoresis -or- >90% reduction in serum M-protein plus urine M-protein < 100 mg on 24 h collection |
Partial Response (PR) |
>50% reduction of serum M-protein plus > 90% reduction in or <200 mg per 24 h urine collection
If serum and urine M-protein unmeasurable and FLC are also unmeasurable, >50% reduction in plasma cells is required in place of M-protein, provided that the baseline percentage in bone marrow is at least 30%. Additionally, a >50% reduction in the size of soft tissue plasmacytomas is also required as measured by FDG18-PET/CT
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Minimal Response (MR) |
≥25% but ≤49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50–89%
If soft tissue plasmacytoma is present, then >50% reduction in size is also required.
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Stable Disease (SD) |
Not meeting criteria for CR, VGPR, PR, MR, or PD. Generally, not recommended for use as an indicator of response |
Progressive Disease (PD) |
Increase of 25% from the lowest confirmed response value in one or more of the following criteria:
Serum M-protein (absolute increased must be >0.5 g/dL)
Serum M-protein increase ≥1 g/dL, if the lowest M component was ≥5 g/dL
Urine M-protein (absolute increase must be ≥200 mg/24 h)
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)
In patients without measurable serum and urine M-protein levels and without measurable involved FLC levels, bone marrow plasma-cell percentage irrespective of baseline status (absolute increase must be ≥10%)
≥50% increase in the size of >1 skeletal or soft tissue lesion, or ≥50% increase in the longest diameter of a previous lesion > 1 cm in short axis (as measured by FDG18 PET/CT)
≥50% increase in circulating plasma cells (minimum of 200 cells per μL) if this is the only measure of disease
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Clinical Relapse |
Any one or more of the following criteria:
Direct indicators increasing disease and/or end-organ dysfunction (i.e., CRAB features)
Development of new soft tissue plasmacytomas or bone lesions (excluding osteoporotic fractures)
Definite increase in the size of existing plasmacytomas or bone lesions by >50% as measured by serial FDG18 PET/CT
Hypercalcemia (>11 mg/dL)
Decrease in hemoglobin of >2 g/dL not related to therapy or other non-myeloma conditions
Rise in serum creatinine by 2 mg/dL or more from the start of therapy attributable to myeloma
Hyperviscosity related to serum paraprotein
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Relapse from CR |
Any one or more of the following
Reappearance of serum or urine M-protein by immunofixation or electrophoresis
Development of >5% plasma cells in the bone marrow
Appearance of any other signs of progression (ie. New plasmacytoma or CRAB features)
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