Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma

[EN] BACKGROUND The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients wi...

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Autores: Mateos Manteca, María Victoria, Dimopoulos, Meletios A., Cavo, Michele, Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Kaplan, Polina, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna M., Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Chiu, Christopher, Wang, Jianping, Carson, Robin, Crist, Wendy, Deraedt, William, Nguyen, Huong, Qi, Ming, San Miguel Izquierdo, Jesús Fernando
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2018
País:España
Recursos:Universidad de Salamanca (USAL)
Repositorio:GREDOS. Repositorio Institucional de la Universidad de Salamanca
OAI Identifier:oai:gredos.usal.es:10366/154454
Acesso em linha:http://hdl.handle.net/10366/154454
Access Level:acceso abierto
Palavra-chave:Mieloma
Aged
Multiple Myeloma
anciano
mieloma múltiple
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repository_id_str
spelling Daratumumab plus bortezomib, melphalan, and prednisone for untreated myelomaMateos Manteca, María VictoriaDimopoulos, Meletios A.Cavo, MicheleSuzuki, KenshiJakubowiak, AndrzejKnop, StefanDoyen, ChantalLucio, PauloNagy, ZsoltKaplan, PolinaPour, LudekCook, MarkGrosicki, SebastianCrepaldi, AndreLiberati, Anna M.Campbell, PhilipShelekhova, TatianaYoon, Sung-SooIosava, GenadiFujisaki, TomoakiGarg, MamtaChiu, ChristopherWang, JianpingCarson, RobinCrist, WendyDeraedt, WilliamNguyen, HuongQi, MingSan Miguel Izquierdo, Jesús FernandoMielomaAgedMultiple Myelomaancianomieloma múltiple[EN] BACKGROUND The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. METHODS In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. RESULTS At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P<0.001). The overall response rate was 90.9% in the daratumumab group, as compared with 73.9% in the control group (P<0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, versus 24.4% (P<0.001). In the daratumumab group, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 105 white cells), as compared with 6.2% of those in the control group (P<0.001). The most common adverse events of grade 3 or 4 were hematologic: neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively). The rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group; the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively. Daratumumabassociated infusion-related reactions occurred in 27.7% of the patients. CONCLUSIONS Among patients with newly diagnosed multiple myeloma who were ineligible for stemcell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without daratumumab. The daratumumab-containing regimen was associated with more grade 3 or 4 infections. (Funded by Janssen Research and Development; ALCYONE ClinicalTrials.gov number, NCT02195479.)202420242018info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10366/154454reponame:GREDOS. Repositorio Institucional de la Universidad de Salamancainstname:Universidad de Salamanca (USAL)EspañolAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:gredos.usal.es:10366/1544542026-06-07T06:28:51Z
dc.title.none.fl_str_mv Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
title Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
spellingShingle Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
Mateos Manteca, María Victoria
Mieloma
Aged
Multiple Myeloma
anciano
mieloma múltiple
title_short Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
title_full Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
title_fullStr Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
title_full_unstemmed Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
title_sort Daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma
dc.creator.none.fl_str_mv Mateos Manteca, María Victoria
Dimopoulos, Meletios A.
Cavo, Michele
Suzuki, Kenshi
Jakubowiak, Andrzej
Knop, Stefan
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Kaplan, Polina
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna M.
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Iosava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Chiu, Christopher
Wang, Jianping
Carson, Robin
Crist, Wendy
Deraedt, William
Nguyen, Huong
Qi, Ming
San Miguel Izquierdo, Jesús Fernando
author Mateos Manteca, María Victoria
author_facet Mateos Manteca, María Victoria
Dimopoulos, Meletios A.
Cavo, Michele
Suzuki, Kenshi
Jakubowiak, Andrzej
Knop, Stefan
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Kaplan, Polina
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna M.
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Iosava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Chiu, Christopher
Wang, Jianping
Carson, Robin
Crist, Wendy
Deraedt, William
Nguyen, Huong
Qi, Ming
San Miguel Izquierdo, Jesús Fernando
author_role author
author2 Dimopoulos, Meletios A.
Cavo, Michele
Suzuki, Kenshi
Jakubowiak, Andrzej
Knop, Stefan
Doyen, Chantal
Lucio, Paulo
Nagy, Zsolt
Kaplan, Polina
Pour, Ludek
Cook, Mark
Grosicki, Sebastian
Crepaldi, Andre
Liberati, Anna M.
Campbell, Philip
Shelekhova, Tatiana
Yoon, Sung-Soo
Iosava, Genadi
Fujisaki, Tomoaki
Garg, Mamta
Chiu, Christopher
Wang, Jianping
Carson, Robin
Crist, Wendy
Deraedt, William
Nguyen, Huong
Qi, Ming
San Miguel Izquierdo, Jesús Fernando
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Mieloma
Aged
Multiple Myeloma
anciano
mieloma múltiple
topic Mieloma
Aged
Multiple Myeloma
anciano
mieloma múltiple
description [EN] BACKGROUND The combination of bortezomib, melphalan, and prednisone is a standard treatment for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation. Daratumumab has shown efficacy in combination with standard-of-care regimens in patients with relapsed or refractory multiple myeloma. METHODS In this phase 3 trial, we randomly assigned 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression. The primary end point was progression-free survival. RESULTS At a median follow-up of 16.5 months in a prespecified interim analysis, the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P<0.001). The overall response rate was 90.9% in the daratumumab group, as compared with 73.9% in the control group (P<0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, versus 24.4% (P<0.001). In the daratumumab group, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 105 white cells), as compared with 6.2% of those in the control group (P<0.001). The most common adverse events of grade 3 or 4 were hematologic: neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively). The rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group; the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively. Daratumumabassociated infusion-related reactions occurred in 27.7% of the patients. CONCLUSIONS Among patients with newly diagnosed multiple myeloma who were ineligible for stemcell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than the same regimen without daratumumab. The daratumumab-containing regimen was associated with more grade 3 or 4 infections. (Funded by Janssen Research and Development; ALCYONE ClinicalTrials.gov number, NCT02195479.)
publishDate 2018
dc.date.none.fl_str_mv 2018
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10366/154454
url http://hdl.handle.net/10366/154454
dc.language.none.fl_str_mv Español
language_invalid_str_mv Español
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 Internacional
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv reponame:GREDOS. Repositorio Institucional de la Universidad de Salamanca
instname:Universidad de Salamanca (USAL)
instname_str Universidad de Salamanca (USAL)
reponame_str GREDOS. Repositorio Institucional de la Universidad de Salamanca
collection GREDOS. Repositorio Institucional de la Universidad de Salamanca
repository.name.fl_str_mv
repository.mail.fl_str_mv
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