Basic Principles

The goals of assessing response differ between clinical practice and clinical trials. In practice, clinicians use various parameters to make an informed judgment about whether a given therapy is effective in a patient with myeloma, and to adjust therapy as needed. This includes assessment of M-protein levels on the basis of published response criteria, as well as other clinical variables. There is room for discretion when certain results are not available or are deemed clinically unnecessary. In clinical trials, however, there is a need to adhere to strict criteria to ensure that reported results are reliable and reproducible, as well as to ensure that results can be compared across clinical trials.

Several well-established response and survival criteria have been developed for myeloma over the years, primarily for use in clinical trials, though they have also been used to guide clinical practice. These criteria define various categories of response. They also define progressive disease, which is important in calculating PFS and event-free survival (EFS). The four most commonly used response criteria are those of the Chronic Leukemia-Myeloma Task Force,7 Southwest Oncology Group (SWOG),89 Eastern Cooperative Oncology Group (ECOG),10 and the European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry/American Bone Marrow Transplant Registry (EBMT/IBMTR/ABMTR).11 Recently the International Myeloma Working Group has published uniform response criteria.11a

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