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Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial

In the ALCYONE trial, daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) reduced the risk of disease progression or death by 50% versus bortezomib, melphalan, and prednisone (VMP) in patients with transplant-ineligible newly diagnosed multiple myeloma. Here, we report a subanalysis of Ea...

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Autores principales: Fujisaki, Tomoaki, Ishikawa, Takayuki, Takamatsu, Hiroyuki, Suzuki, Kenshi, Min, Chang-Ki, Lee, Jae Hoon, Wang, Jianping, Carson, Robin, Crist, Wendy, Qi, Ming, Nagafuji, Koji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900260/
https://www.ncbi.nlm.nih.gov/pubmed/31620815
http://dx.doi.org/10.1007/s00277-019-03794-9
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author Fujisaki, Tomoaki
Ishikawa, Takayuki
Takamatsu, Hiroyuki
Suzuki, Kenshi
Min, Chang-Ki
Lee, Jae Hoon
Wang, Jianping
Carson, Robin
Crist, Wendy
Qi, Ming
Nagafuji, Koji
author_facet Fujisaki, Tomoaki
Ishikawa, Takayuki
Takamatsu, Hiroyuki
Suzuki, Kenshi
Min, Chang-Ki
Lee, Jae Hoon
Wang, Jianping
Carson, Robin
Crist, Wendy
Qi, Ming
Nagafuji, Koji
author_sort Fujisaki, Tomoaki
collection PubMed
description In the ALCYONE trial, daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) reduced the risk of disease progression or death by 50% versus bortezomib, melphalan, and prednisone (VMP) in patients with transplant-ineligible newly diagnosed multiple myeloma. Here, we report a subanalysis of East Asian patients from ALCYONE. After a median follow-up of 17.1 and 15.9 months for Japanese (n = 50) and Korean (n = 41) patients, respectively, median progression-free survival for D-VMP versus VMP was not reached (NR) versus 20.7 months in Japanese patients and NR versus 14.0 months in Korean patients. The overall response rate for D-VMP versus VMP was 96% versus 92% in Japanese patients and 91% versus 61% in Korean patients. Using next-generation sequencing, minimal residual disease negativity at 10(−5) sensitivity for D-VMP versus VMP was 33% versus 8% among Japanese patients and 17% versus 0% among Korean patients. Rates of any grade and grade 3/4 pneumonia were consistent with the rates observed for the global safety population. Similar efficacy and safety findings were observed in the combined Japanese and Korean subgroup and ≥ 75 years of age subgroup. In conclusion, D-VMP was safe and efficacious in East Asian patients, consistent with the global ALCYONE population. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00277-019-03794-9) contains supplementary material, which is available to authorized users.
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spelling pubmed-69002602019-12-20 Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial Fujisaki, Tomoaki Ishikawa, Takayuki Takamatsu, Hiroyuki Suzuki, Kenshi Min, Chang-Ki Lee, Jae Hoon Wang, Jianping Carson, Robin Crist, Wendy Qi, Ming Nagafuji, Koji Ann Hematol Original Article In the ALCYONE trial, daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) reduced the risk of disease progression or death by 50% versus bortezomib, melphalan, and prednisone (VMP) in patients with transplant-ineligible newly diagnosed multiple myeloma. Here, we report a subanalysis of East Asian patients from ALCYONE. After a median follow-up of 17.1 and 15.9 months for Japanese (n = 50) and Korean (n = 41) patients, respectively, median progression-free survival for D-VMP versus VMP was not reached (NR) versus 20.7 months in Japanese patients and NR versus 14.0 months in Korean patients. The overall response rate for D-VMP versus VMP was 96% versus 92% in Japanese patients and 91% versus 61% in Korean patients. Using next-generation sequencing, minimal residual disease negativity at 10(−5) sensitivity for D-VMP versus VMP was 33% versus 8% among Japanese patients and 17% versus 0% among Korean patients. Rates of any grade and grade 3/4 pneumonia were consistent with the rates observed for the global safety population. Similar efficacy and safety findings were observed in the combined Japanese and Korean subgroup and ≥ 75 years of age subgroup. In conclusion, D-VMP was safe and efficacious in East Asian patients, consistent with the global ALCYONE population. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00277-019-03794-9) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2019-10-16 2019 /pmc/articles/PMC6900260/ /pubmed/31620815 http://dx.doi.org/10.1007/s00277-019-03794-9 Text en © The Author(s) 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Fujisaki, Tomoaki
Ishikawa, Takayuki
Takamatsu, Hiroyuki
Suzuki, Kenshi
Min, Chang-Ki
Lee, Jae Hoon
Wang, Jianping
Carson, Robin
Crist, Wendy
Qi, Ming
Nagafuji, Koji
Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title_full Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title_fullStr Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title_full_unstemmed Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title_short Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial
title_sort daratumumab plus bortezomib, melphalan, and prednisone in east asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 alcyone trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900260/
https://www.ncbi.nlm.nih.gov/pubmed/31620815
http://dx.doi.org/10.1007/s00277-019-03794-9
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