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).
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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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