IMWG response and MRD criteria
| Criteria . | Definition . | |
|---|---|---|
| Standard IMWG response criteria | ||
| Complete response | Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirate | |
| Stringent complete response | CR as defined above plus normal free light-chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (ĸ/λ ratio ≤4:1 or ≥1:2 for ĸ and λ patients, respectively, after counting ≥100 plasma cells) | |
| IMWG MRD criteria (requires a CR as defined above) | ||
| Flow MRD-negative | Absence of phenotypically aberrant clonal plasma cells by NGF on bone marrow aspirates using the EuroFlow standard operation procedure for MRD detection in multiple myeloma (or validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells or higher | |
| Sequencing MRD-negative | Absence of clonal plasma cells by NGS on bone marrow aspirate in which presence of a clone is defined as less than 2 identical sequencing reads obtained after DNA sequencing of bone marrow aspirates using the LymphoSIGHT/ClonoSEQ platform (or a validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells or higher | |
| Imaging plus MRD-negative | MRD negativity as defined by NGF or NGS plus disappearance of every area of increased tracer uptake found at baseline or a preceding PET-CT or decrease to less than mediastinal blood pool standardized uptake value or decrease to less than that of surrounding normal tissue | |
| Sustained MRD-negative | MRD negativity in the marrow (NGF or NGS, or both) and by imaging as defined above, confirmed minimum of 1 y apart. Subsequent evaluations can be used to further specify the duration of negativity (e.g, MRD-negative at 5 y) | |
| Criteria . | Definition . | |
|---|---|---|
| Standard IMWG response criteria | ||
| Complete response | Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirate | |
| Stringent complete response | CR as defined above plus normal free light-chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry (ĸ/λ ratio ≤4:1 or ≥1:2 for ĸ and λ patients, respectively, after counting ≥100 plasma cells) | |
| IMWG MRD criteria (requires a CR as defined above) | ||
| Flow MRD-negative | Absence of phenotypically aberrant clonal plasma cells by NGF on bone marrow aspirates using the EuroFlow standard operation procedure for MRD detection in multiple myeloma (or validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells or higher | |
| Sequencing MRD-negative | Absence of clonal plasma cells by NGS on bone marrow aspirate in which presence of a clone is defined as less than 2 identical sequencing reads obtained after DNA sequencing of bone marrow aspirates using the LymphoSIGHT/ClonoSEQ platform (or a validated equivalent method) with a minimum sensitivity of 1 in 105 nucleated cells or higher | |
| Imaging plus MRD-negative | MRD negativity as defined by NGF or NGS plus disappearance of every area of increased tracer uptake found at baseline or a preceding PET-CT or decrease to less than mediastinal blood pool standardized uptake value or decrease to less than that of surrounding normal tissue | |
| Sustained MRD-negative | MRD negativity in the marrow (NGF or NGS, or both) and by imaging as defined above, confirmed minimum of 1 y apart. Subsequent evaluations can be used to further specify the duration of negativity (e.g, MRD-negative at 5 y) | |