The real-world outcomes of multiple myeloma patients treated with daratumumab.

Most patients cannot be included in randomized clinical trials. We report real-world outcomes of all Danish patients with multiple myeloma (MM) treated with daratumumab-based regimens until 1 January 2019.<h4>Methods</h4>Information of 635 patients treated with daratumumab was collected...

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Autores principales:	Agoston Gyula Szabo, Tobias Wirenfeldt Klausen, Mette Bøegh Levring, Birgitte Preiss, Carsten Helleberg, Marie Fredslund Breinholt, Emil Hermansen, Lise Mette Rahbek Gjerdrum, Søren Thorgaard Bønløkke, Katrine Nielsen, Eigil Kjeldsen, Katrine Fladeland Iversen, Elena Manuela Teodorescu, Marveh Dokhi, Eva Kurt, Casper Strandholdt, Mette Klarskov Andersen, Annette Juul Vangsted
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/3a1957b6a5774014bba30b82888f0eeb
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spelling	oai:doaj.org-article:3a1957b6a5774014bba30b82888f0eeb2021-12-02T20:19:14ZThe real-world outcomes of multiple myeloma patients treated with daratumumab.1932-620310.1371/journal.pone.0258487https://doaj.org/article/3a1957b6a5774014bba30b82888f0eeb2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0258487https://doaj.org/toc/1932-6203Most patients cannot be included in randomized clinical trials. We report real-world outcomes of all Danish patients with multiple myeloma (MM) treated with daratumumab-based regimens until 1 January 2019.<h4>Methods</h4>Information of 635 patients treated with daratumumab was collected retrospectively and included lines of therapy (LOT), hematologic responses according to the International Myeloma Working Group recommendations, time to next treatment (TNT) and the cause of discontinuation of treatment. Baseline characteristics were acquired from the validated Danish Multiple Myeloma Registry (DMMR).<h4>Results</h4>Daratumumab was administrated as monotherapy (Da-mono) in 27.7%, in combination with immunomodulatory drugs (Da-IMiD) in 57.3%, in combination with proteasome inhibitors (Da-PI) in 11.2% and in other combinations (Da-other) in 3.8% of patients. The median number of lines of therapy given before daratumumab was 5 for Da-mono, 3 for Da-IMiD, 4 for Da-PI, and 2 for Da-other. In Da-mono, overall response rate (ORR) was 44.9% and median time to next treatment (mTNT) was 4.9 months. In Da-IMiD, ORR was 80.5%, and mTNT was 16.1 months. In Da-PI, OOR was 60.6% and mTNT was 5.3 months. In patients treated with Da-other, OOR was 54,2% and mTNT was 5.6 months. The use of daratumumab in early LOT was associated with longer TNT (p<0.0001). Patients with amplification 1q had outcome comparable to standard risk patients, while patients with t(4;14), t(14;16) or del17p had worse outcome (p = 0.0001). Multivariate analysis indicated that timing of treatment (timing of daratumumab in the sequence of all LOT that the patients received throughout the course of their disease) was the most important factor for outcome (p<0.0001).<h4>Conclusion</h4>The real-world outcomes of multiple myeloma patients treated with daratumumab are worse than the results of clinical trials. Outcomes achieved with daratumumab were best when daratumumab was used in combination with IMIDs and in early LOT. Patients with high-risk CA had worse outcomes, but patients with amp1q had similar outcomes to standard-risk patients.Agoston Gyula SzaboTobias Wirenfeldt KlausenMette Bøegh LevringBirgitte PreissCarsten HellebergMarie Fredslund BreinholtEmil HermansenLise Mette Rahbek GjerdrumSøren Thorgaard BønløkkeKatrine NielsenEigil KjeldsenKatrine Fladeland IversenElena Manuela TeodorescuMarveh DokhiEva KurtCasper StrandholdtMette Klarskov AndersenAnnette Juul VangstedPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0258487 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Agoston Gyula Szabo Tobias Wirenfeldt Klausen Mette Bøegh Levring Birgitte Preiss Carsten Helleberg Marie Fredslund Breinholt Emil Hermansen Lise Mette Rahbek Gjerdrum Søren Thorgaard Bønløkke Katrine Nielsen Eigil Kjeldsen Katrine Fladeland Iversen Elena Manuela Teodorescu Marveh Dokhi Eva Kurt Casper Strandholdt Mette Klarskov Andersen Annette Juul Vangsted The real-world outcomes of multiple myeloma patients treated with daratumumab.
description	Most patients cannot be included in randomized clinical trials. We report real-world outcomes of all Danish patients with multiple myeloma (MM) treated with daratumumab-based regimens until 1 January 2019.<h4>Methods</h4>Information of 635 patients treated with daratumumab was collected retrospectively and included lines of therapy (LOT), hematologic responses according to the International Myeloma Working Group recommendations, time to next treatment (TNT) and the cause of discontinuation of treatment. Baseline characteristics were acquired from the validated Danish Multiple Myeloma Registry (DMMR).<h4>Results</h4>Daratumumab was administrated as monotherapy (Da-mono) in 27.7%, in combination with immunomodulatory drugs (Da-IMiD) in 57.3%, in combination with proteasome inhibitors (Da-PI) in 11.2% and in other combinations (Da-other) in 3.8% of patients. The median number of lines of therapy given before daratumumab was 5 for Da-mono, 3 for Da-IMiD, 4 for Da-PI, and 2 for Da-other. In Da-mono, overall response rate (ORR) was 44.9% and median time to next treatment (mTNT) was 4.9 months. In Da-IMiD, ORR was 80.5%, and mTNT was 16.1 months. In Da-PI, OOR was 60.6% and mTNT was 5.3 months. In patients treated with Da-other, OOR was 54,2% and mTNT was 5.6 months. The use of daratumumab in early LOT was associated with longer TNT (p<0.0001). Patients with amplification 1q had outcome comparable to standard risk patients, while patients with t(4;14), t(14;16) or del17p had worse outcome (p = 0.0001). Multivariate analysis indicated that timing of treatment (timing of daratumumab in the sequence of all LOT that the patients received throughout the course of their disease) was the most important factor for outcome (p<0.0001).<h4>Conclusion</h4>The real-world outcomes of multiple myeloma patients treated with daratumumab are worse than the results of clinical trials. Outcomes achieved with daratumumab were best when daratumumab was used in combination with IMIDs and in early LOT. Patients with high-risk CA had worse outcomes, but patients with amp1q had similar outcomes to standard-risk patients.
format	article
author	Agoston Gyula Szabo Tobias Wirenfeldt Klausen Mette Bøegh Levring Birgitte Preiss Carsten Helleberg Marie Fredslund Breinholt Emil Hermansen Lise Mette Rahbek Gjerdrum Søren Thorgaard Bønløkke Katrine Nielsen Eigil Kjeldsen Katrine Fladeland Iversen Elena Manuela Teodorescu Marveh Dokhi Eva Kurt Casper Strandholdt Mette Klarskov Andersen Annette Juul Vangsted
author_facet	Agoston Gyula Szabo Tobias Wirenfeldt Klausen Mette Bøegh Levring Birgitte Preiss Carsten Helleberg Marie Fredslund Breinholt Emil Hermansen Lise Mette Rahbek Gjerdrum Søren Thorgaard Bønløkke Katrine Nielsen Eigil Kjeldsen Katrine Fladeland Iversen Elena Manuela Teodorescu Marveh Dokhi Eva Kurt Casper Strandholdt Mette Klarskov Andersen Annette Juul Vangsted
author_sort	Agoston Gyula Szabo
title	The real-world outcomes of multiple myeloma patients treated with daratumumab.
title_short	The real-world outcomes of multiple myeloma patients treated with daratumumab.
title_full	The real-world outcomes of multiple myeloma patients treated with daratumumab.
title_fullStr	The real-world outcomes of multiple myeloma patients treated with daratumumab.
title_full_unstemmed	The real-world outcomes of multiple myeloma patients treated with daratumumab.
title_sort	real-world outcomes of multiple myeloma patients treated with daratumumab.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/3a1957b6a5774014bba30b82888f0eeb
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The real-world outcomes of multiple myeloma patients treated with daratumumab.

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