$Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma$
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Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma

Introduction: Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients. Methods:...

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Autores principales:	Edvan de Queiroz Crusoé, Flávia Cristina Fernandes Pimenta, Angelo Maiolino, Nelson Siqueira de Castro, Huiling Pei, Damila Trufelli, Mariana Fernandez, Luciana Barreto Herriot
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Daratumumab Monoclonal antibody Multiple myeloma Early access protocol Brazil Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/1f1e7ed4750b4a32812d19e02ced92d7
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spelling	oai:doaj.org-article:1f1e7ed4750b4a32812d19e02ced92d72021-11-04T04:37:04ZResults of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma2531-137910.1016/j.htct.2020.07.005https://doaj.org/article/1f1e7ed4750b4a32812d19e02ced92d72021-10-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2531137920301231https://doaj.org/toc/2531-1379Introduction: Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients. Methods: Patients with RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and IMiD received daratumumab, 16 mg/kg, intravenously weekly for 8 weeks, biweekly for 16 weeks, and every 4 weeks thereafter until disease progression, unacceptable toxicity, loss of clinical benefit, or study conclusion or if daratumumab became available with reimbursement. Results: Forty-nine patients received ≥1 dose of daratumumab. The median (range) duration of treatment was 6.4 (0.3−11.8) months, with a median (range) of 8 (1−13) treatment cycles. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 38.8% of patients, most frequently neutropenia and pneumonia (10.2% each). Seven (14.3%) patients discontinued treatment due to TEAEs; 3 patients discontinued due to daratumumab-related TEAEs. Serious TEAEs occurred in 38.8% of patients. Infusion-related reactions were reported in 25 (51.0%) patients, were primarily grade 1/2, and the majority (23 patients) occurred during the first infusion. Twenty (40.8%) patients achieved a partial response or better; median progression-free survival was 8.25 (95% confidence interval, 5.55–17.54) months. Conclusion: In this EAP, daratumumab monotherapy in Brazilian patients showed a safety and efficacy profile consistent with clinical studies of daratumumab monotherapy in patients with heavily pretreated RRMM.ClinicalTrials.gov identifier: NCT02477891.Edvan de Queiroz CrusoéFlávia Cristina Fernandes PimentaAngelo MaiolinoNelson Siqueira de CastroHuiling PeiDamila TrufelliMariana FernandezLuciana Barreto HerriotElsevierarticleDaratumumabMonoclonal antibodyMultiple myelomaEarly access protocolBrazilDiseases of the blood and blood-forming organsRC633-647.5ENHematology, Transfusion and Cell Therapy, Vol 43, Iss 4, Pp 417-423 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Daratumumab Monoclonal antibody Multiple myeloma Early access protocol Brazil Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Daratumumab Monoclonal antibody Multiple myeloma Early access protocol Brazil Diseases of the blood and blood-forming organs RC633-647.5 Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
description	Introduction: Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients. Methods: Patients with RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and IMiD received daratumumab, 16 mg/kg, intravenously weekly for 8 weeks, biweekly for 16 weeks, and every 4 weeks thereafter until disease progression, unacceptable toxicity, loss of clinical benefit, or study conclusion or if daratumumab became available with reimbursement. Results: Forty-nine patients received ≥1 dose of daratumumab. The median (range) duration of treatment was 6.4 (0.3−11.8) months, with a median (range) of 8 (1−13) treatment cycles. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 38.8% of patients, most frequently neutropenia and pneumonia (10.2% each). Seven (14.3%) patients discontinued treatment due to TEAEs; 3 patients discontinued due to daratumumab-related TEAEs. Serious TEAEs occurred in 38.8% of patients. Infusion-related reactions were reported in 25 (51.0%) patients, were primarily grade 1/2, and the majority (23 patients) occurred during the first infusion. Twenty (40.8%) patients achieved a partial response or better; median progression-free survival was 8.25 (95% confidence interval, 5.55–17.54) months. Conclusion: In this EAP, daratumumab monotherapy in Brazilian patients showed a safety and efficacy profile consistent with clinical studies of daratumumab monotherapy in patients with heavily pretreated RRMM.ClinicalTrials.gov identifier: NCT02477891.
format	article
author	Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot
author_facet	Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot
author_sort	Edvan de Queiroz Crusoé
title	Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
title_short	Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
title_full	Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
title_fullStr	Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
title_full_unstemmed	Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
title_sort	results of the daratumumab monotherapy early access treatment protocol in patients from brazil with relapsed or refractory multiple myeloma
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/1f1e7ed4750b4a32812d19e02ced92d7
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Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma

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