文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

达雷妥尤单抗联合硼替佐米、美法仑和泼尼松治疗未接受移植的东亚多发性骨髓瘤患者:随机 3 期 ALCYONE 试验的亚组分析。

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

机构信息

Department of Internal Medicine, Matsuyama Red-Cross Hospital, Ehime, Japan.

Department of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.

出版信息

Ann Hematol. 2019 Dec;98(12):2805-2814. doi: 10.1007/s00277-019-03794-9. Epub 2019 Oct 16.


DOI:10.1007/s00277-019-03794-9
PMID:31620815
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6900260/
Abstract

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 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.

摘要

在 ALCYONE 试验中,与硼替佐米、马法兰和泼尼松(VMP)相比,达雷妥尤单抗联合硼替佐米、马法兰和泼尼松(D-VMP)降低了不适合移植的新诊断多发性骨髓瘤患者疾病进展或死亡的风险 50%。在此,我们报告了来自 ALCYONE 的东亚患者的亚组分析。在日本患者(n=50)和韩国患者(n=41)的中位随访分别为 17.1 和 15.9 个月后,D-VMP 与 VMP 相比,日本患者的中位无进展生存期未达到(NR)与 20.7 个月,韩国患者的中位无进展生存期 NR 与 14.0 个月。D-VMP 与 VMP 的总体缓解率在日本患者中分别为 96%和 92%,在韩国患者中分别为 91%和 61%。使用下一代测序,D-VMP 与 VMP 的微小残留病阴性率在日本患者中为 10 灵敏度 33%与 8%,在韩国患者中为 17%与 0%。任何级别和 3/4 级肺炎的发生率与全球安全性人群观察到的发生率一致。在日本和韩国联合亚组和≥75 岁年龄亚组中观察到了相似的疗效和安全性结果。总之,D-VMP 在东亚患者中是安全有效的,与全球 ALCYONE 人群一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f60/6900260/da97abd50091/277_2019_3794_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f60/6900260/da97abd50091/277_2019_3794_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f60/6900260/da97abd50091/277_2019_3794_Fig1_HTML.jpg

相似文献

[1]
Daratumumab plus bortezomib, melphalan, and prednisone in East Asian patients with non-transplant multiple myeloma: subanalysis of the randomized phase 3 ALCYONE trial.

Ann Hematol. 2019-10-16

[2]
Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial.

Lancet. 2019-12-10

[3]
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE.

Clin Lymphoma Myeloma Leuk. 2021-11

[4]
Comparative Efficacy of Bortezomib, Melphalan, and Prednisone (VMP) With or Without Daratumumab Versus VMP Alone in the Treatment of Newly Diagnosed Multiple Myeloma: Propensity Score Matching of ALCYONE and VISTA Phase III Studies.

Clin Lymphoma Myeloma Leuk. 2020-7

[5]
Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Transplant-ineligible Asian Patients With Newly Diagnosed Multiple Myeloma: The Phase 3 OCTANS Study.

Clin Lymphoma Myeloma Leuk. 2023-6

[6]
Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Standard of Care in Latin America for Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Propensity Score Matching Analysis.

Adv Ther. 2020-12

[7]
Sequential therapy of four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma.

Ann Hematol. 2019-11-25

[8]
Daratumumab, bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone alone in transplant-ineligible Asian patients with newly diagnosed multiple myeloma: final analysis of the phase 3 OCTANS Study.

Ann Hematol. 2025-1

[9]
Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE.

Blood. 2022-1-27

[10]
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma.

N Engl J Med. 2017-12-12

引用本文的文献

[1]
Daratumumab and antineoplastic therapy versus antineoplastic therapy only for adults with newly diagnosed multiple myeloma ineligible for transplant.

Cochrane Database Syst Rev. 2024-5-2

[2]
Primary analysis of a prospective cohort study of Japanese patients with plasma cell neoplasms in the novel drug era (2016-2021).

Int J Hematol. 2024-6

[3]
Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab.

Clin Pharmacokinet. 2023-6

[4]
Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA.

Ann Hematol. 2023-4

[5]
Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial.

Int J Hematol. 2021-12

[6]
[Progress in the treatment of multiple myeloma with daratumumab].

Zhonghua Xue Ye Xue Za Zhi. 2021-3-14

[7]
The Role of Monoclonal Antibodies in the First-Line Treatment of Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma.

Pharmaceuticals (Basel). 2020-12-29

本文引用的文献

[1]
Daratumumab plus lenalidomide and dexamethasone lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX.

Haematologica. 2018-9-20

[2]
Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: subgroup analyses of the phase 3 POLLUX study.

Blood Cancer J. 2018-5-1

[3]
Recent advances in the management of multiple myeloma: clinical impact based on resource-stratification. Consensus statement of the Asian Myeloma Network at the 16th international myeloma workshop.

Leuk Lymphoma. 2018-10

[4]
Safety and efficacy of daratumumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma.

Int J Hematol. 2018-4

[5]
Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma.

N Engl J Med. 2017-12-12

[6]
Safety and efficacy of daratumumab in Japanese patients with relapsed or refractory multiple myeloma: a multicenter, phase 1, dose-escalation study.

Int J Hematol. 2017-10

[7]
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma.

N Engl J Med. 2016-10-6

[8]
Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma.

N Engl J Med. 2016-8-25

[9]
The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces Programmed Cell Death via Fcγ Receptor-Mediated Cross-Linking.

J Immunol. 2016-8-1

[10]
Daratumumab depletes CD38+ immune regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma.

Blood. 2016-7-21

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索