Complete response (CR) |
Complete disappearance of all previously observed abnormalities on radiographic imaging. For patients with a secretory plasmacytoma, a disappearance of monoclonal protein from serum and/or urine. For SBP, the initial radiological abnormalities on MRI or CT should regress or stabilize during an observation time of at least 12 months to fulfill the requirements for a CR. For EMP, the disappearance of soft tissue mass is required for the definition of CR |
Very good partial response (VGPR) |
A CR with regard to clinical and radiological signs, but with a positive immunofixation or ≥ 90% reduction in serum monoclonal protein plus urine monoclonal protein level < 100 mg/24 h. |
Partial response (PR) |
A ≥ 50% decrease in serum and/or urine monoclonal protein. For non-secretory SP, radiological features (MRI/CT) or local assessment is needed. In EMP patients, a 30% decrease in the diameter of target lesions should be observed. |
Stable disease (SD) |
Insufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
Progressive disease (PD) |
The development of new lesions or an increase of at least 20% in the size of existing lesions, the apparition of a myeloma defining event, and finally an increase of > 25% from lowest response value in serum and/or urine monoclonal protein. |