New uniform response criteria are required to adequately assess clinical outcomes in myeloma. The European Group for Blood and Bone Marrow Transplant/International Bone Marrow Transplant Registry criteria have been expanded, clariﬁed and updated to provide a new comprehensive evalua- tion system. Categories for stringent complete response and very good partial response are added. The serum free light- chain assay is included to allow evaluation of patients with oligo-secretory disease. Inconsistencies in prior criteria are clariﬁed making conﬁrmation of response and disease progres- sion easier to perform. Emphasis is placed upon time to event and duration of response as critical end points. The require- ments necessary to use overall survival duration as the ultimate end point are discussed. It is anticipated that the International Response Criteria for multiple myeloma will be widely used in future clinical trials of myeloma.
BGM Durie, J-L Harousseau, JS Miguel, J Blade, B Barlogie, K Anderson, M Gertz, M Dimopoulos, J Westin, P Sonneveld, H Ludwig, G Gahrton, M Beksac, J Crowley, A Belch, M Boccadaro, I Turesson, D Joshua, D Vesole, R Kyle, R Alexanian, G Tricot, M Attal, G Merlini, R Powles, P Richardson, K Shimizu, P Tosi, G Morgan and SV Rajkumar on behalf of the International Myeloma Working Group
Leukemia advance online publication, 20 July 2006; doi:10.1038/sj.leu.2404284