2026-09-05T20:14:35Zhttps://gredos.usal.es/oai/request

oai:gredos.usal.es:10366/1462042025-04-30T20:48:45Zcom_10366_133043com_10366_4576com_10366_3823col_10366_135272

Laubach, Jacob P. Moslehi, Javid J. Francis, Sanjeev A. San Miguel, Jesús F. Sonneveld, Pieter Orlowski, Robert Z. Moreau, Philippe Rosiñol, Laura Faber, Edward A. Voorhees, Peter Mateos Manteca, María Victoria Marquez, Loreta Feng, Huaibao Desai, Avinash van de Velde, Helgi Elliott, Jennifer Shi, Hongliang Dow, Edward Jobanputra, Nishith Esseltine, Dixie-Lee Niculescu, Liviu Anderson, Kenneth C. Lonial, Sagar Richardson, Paul G. 2021-05-24T09:03:41Z 2021-05-24T09:03:41Z 2017-05 Laubach, J.P., Moslehi, J.J., Francis, S.A., San Miguel, J.F., Sonneveld, P., Orlowski, R.Z., Moreau, P., Rosiñol, L., Faber, E.A., Jr, Voorhees, P., Mateos, M.-V., Marquez, L., Feng, H., Desai, A., van de Velde, H., Elliott, J., Shi, H., Dow, E., Jobanputra, N., Esseltine, D.-L., Niculescu, L., Anderson, K.C., Lonial, S. and Richardson, P.G. (2017), A retrospective analysis of 3954 patients in phase 2/3 trials of bortezomib for the treatment of multiple myeloma: towards providing a benchmark for the cardiac safety profile of proteasome inhibition in multiple myeloma. Br J Haematol, 178: 547-560. https://doi.org/10.1111/bjh.14708 0007-1048 http://hdl.handle.net/10366/146204 10.1111/bjh.14708 [EN] This retrospective analysis aimed to establish the overall cardiac safety profile of bortezomib using patient-level data from one phase 2 and seven phase 3 studies in previously untreated and relapsed/refractory multiple myeloma (MM). Seven clinically relevant primary [congestive heart failure (CHF), arrhythmias, ischaemic heart disease (IHD), cardiac death] and secondary (hypertension, dyspnoea, oedema) cardiac endpoints were defined based on MedDRA v16.0 preferred terms. 2509 bortezomib-treated patients and 1445 patients in non-bortezomib-based control arms were included. The incidence of grade ≥3 CHF was 1·3–4·0% in studies in relapsed/refractory MM and 1·2–4·7% in previously untreated MM (2·0–7·6% all grades), with no significant differences between bortezomib- and non-bortezomib-based arms in comparative studies. Incidences of arrhythmias (1·3–5·9% grade ≥2; 0·6–4·1% grade ≥3), IHD (1·2–2·9% all grades; 0·4–2·7% grade ≥3) and cardiac death (0–1·4%) were low, with no differences between bortezomib-based and non-bortezomib-based arms. eng http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Attribution-NonCommercial-NoDerivatives 4.0 Internacional Cardiac Bortezomib Cardio-oncology Multiple myeloma A retrospective analysis of 3954 patients in phase 2/3 trials of bortezomib for the treatment of multiple myeloma: towards providing a benchmark for the cardiac safety profile of proteasome inhibition in multiple myeloma info:eu-repo/semantics/article