title: Response Assessment in Myeloma: Practical Manual on Consistent Reporting in an Era of Dramatic Therapeutic Advances.
abstract: The understanding and treatment of multiple myeloma (MM) have dramatically improved in recent years. However, accurate assessment of the response of myeloma to therapy and its subsequent relapse remains a difficult task. Criteria have changed over time and new parameters have recently been incorporated to evaluate minimal residual disease status. We present a practical approach to assess response and relapse/progression in myeloma in the context of its treatment. A robust reporting schema is crucial to correctly evaluate any treatment protocol and compare results across trials. MM is a highly heterogeneous disease with multifarious manifestations. To assess the tumor load decline after treatment and its increase during relapse/progression, numerous parameters need to be taken into account. As our ability and the tools to measure low levels of disease have improved over time, so have the accepted definitions of response, most recently in August 2016. The goal of this article is to define, describe, and clarify the practical methodological aspects of disease evaluation in response to therapy and in progression or relapse. We expect this practical manual will help myeloma professionals and research workers in data collection for registries and databases and clinical trial reporting.
authors.affiliation: INSERM, UMR_S 938, Proliferation and Differentiation of Stem Cells, F-75012 Paris, France; AP-HP, Hôpital Saint Antoine, Département d'hématologie et thérapie cellulaire, F-75012 Paris, France; Université Pierre et Marie Curie, Paris 6, Paris, France. Electronic address: laurent.garderet@aphp.fr.
authors.forename: Laurent
authors.initials: L
authors.lastname: Garderet
authors.affiliation: Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Anita
authors.initials: A
authors.lastname: D'Souza
authors.affiliation: Clinical Trials Office, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Paulette
authors.initials: P
authors.lastname: Jacobs
authors.affiliation: EBMT Data Office Leiden, Department of Medical Statistics and Bioinformatics, S-05-P, Leiden University Medical Center, Poortgebouw-Noord, Room 1.07, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Anja
authors.initials: A
authors.lastname: van Biezen
authors.affiliation: Department of Internal Medicine V, Hematology, Oncology and Rheumatology, Amyloidosis Center, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schönland
authors.affiliation: Department of Stem Cell Transplantation, University Hospital Hamburg-Eppendorf, Martinistrasse 52, D-20246 Hamburg, Germany.
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Kroeger
authors.affiliation: Department of Hematology, Queens University, Belfast, United Kingdom.
authors.forename: Curly
authors.initials: C
authors.lastname: Morris
authors.affiliation: Center for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Parameswaran
authors.initials: P
authors.lastname: Hari
mesh_terms: D018450:Disease Progression; D006801:Humans; D009101:Multiple Myeloma / Q000628:therapy*; D016896:Treatment Outcome
keywords: Myeloma; Relapse; Response