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Challenges in designing and running smouldering myeloma interventional clinical trials

Lecat, Catherine; Boyle, Eileen M; Hughes, Daniel; Lee, Lydia; Smith, Dean; Bygrave, Ceri; Ramasamy, Karthik; (2024) Challenges in designing and running smouldering myeloma interventional clinical trials. eJHaem 10.1002/jha2.880. (In press). Green open access

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Abstract

Smouldering myeloma (SMM) is a heterogeneous, precursor condition to multiple myeloma (MM). SMM patients have either a serum M-protein ≥30 g/L or clonal bone marrow (BM) plasma cells of 10–59% but the absence of myeloma-defining events1. The current standard of care for SMM is observation. The risk of progression to MM is 10% / year for the first 5 years after diagnosis. However, those with high-risk disease have > 50% chance of progression within 2 years based on the International Myeloma Working Group (IMWG) risk model [1]. Two clinical trials using lenalidomide showed a significant delay in MM progression and end-organ damage [2, 3]. However, there are several challenges when designing interventional SMM trials (Figure 1).

Type: Article
Title: Challenges in designing and running smouldering myeloma interventional clinical trials
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/jha2.880
Publisher version: http://dx.doi.org/10.1002/jha2.880
Language: English
Additional information: Copyright © 2024 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, https://creativecommons.org/licenses/by/4.0/, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: Clinical trial, multiple myeloma, precursor disease, smouldering myeloma
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Haematology
URI: https://discovery.ucl.ac.uk/id/eprint/10190323
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