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A multicenter, phase Ib study of subcutaneous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

作者信息

Quach Hang, Parmar Gurdeep, Ocio Enrique M, Prince H Miles, Oriol Albert, Crowther Helen, Tsukada Nobuhiro, Bories Pierre, Madan Sumit, Nathwani Nitya, Sunami Kazutaka, Semiond Dorothee, Yu Disa, Cordero Paul, Macé Sandrine, Suzan Florence, Moreau Philippe

机构信息

Dept. of Hematology, St Vincent's Hospital, University of Melbourne,.

Illawarra Cancer Care Centre, Wollongong, NSW, Australia.

出版信息

Haematologica. 2024 Dec 1;109(12):4078-4082. doi: 10.3324/haematol.2023.284730.

DOI:10.3324/haematol.2023.284730
PMID:39157871
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11609800/
Abstract
摘要

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1
A multicenter, phase Ib study of subcutaneous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.一项关于皮下注射isatuximab联合泊马度胺和地塞米松治疗复发/难治性多发性骨髓瘤患者的多中心1b期研究。
Haematologica. 2024 Dec 1;109(12):4078-4082. doi: 10.3324/haematol.2023.284730.
2
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.依沙佐米联合泊马度胺和低剂量地塞米松与泊马度胺和低剂量地塞米松治疗复发/难治性多发性骨髓瘤患者（ICARIA-MM）：一项随机、多中心、开放性、3 期研究。
Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14.
3
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study.依沙佐米联合泊马度胺和低剂量地塞米松与泊马度胺和低剂量地塞米松治疗复发/难治性多发性骨髓瘤患者（ICARIA-MM）：一项随机、3 期研究的随访分析。
Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10.
4
Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis.依既往治疗线数和难治状态分层的复发/难治性多发性骨髓瘤患者中伊沙佐米联合泊马度胺和地塞米松治疗：ICARIA-MM 亚组分析。
Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.
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EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma.EMA 审查伊沙妥昔单抗联合泊马度胺和地塞米松治疗复发和难治性多发性骨髓瘤的成人患者。
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Isatuximab: A Review of Its Use in Multiple Myeloma.依沙妥昔单抗：在多发性骨髓瘤中的应用评价。
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Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics.ICARIA-MM 研究中伴有高危细胞遗传学的复发/难治性多发性骨髓瘤患者的亚组分析。
Br J Haematol. 2021 Jul;194(1):120-131. doi: 10.1111/bjh.17499. Epub 2021 May 25.
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Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.isatuximab、卡非佐米和地塞米松用于复发多发性骨髓瘤（IKEMA）：一项多中心、开放标签、随机3期试验
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Expert Rev Hematol. 2021 May;14(5):419-427. doi: 10.1080/17474086.2021.1924052. Epub 2021 May 16.
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Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma.在多发性骨髓瘤患者中，与泊马度胺/地塞米松联合治疗时，进行暴露-反应分析以选择/确认伊沙妥昔单抗的最佳剂量方案。
CPT Pharmacometrics Syst Pharmacol. 2022 Jun;11(6):766-777. doi: 10.1002/psp4.12789. Epub 2022 Apr 17.

引用本文的文献

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Subcutaneous administration of isatuximab in patients with multiple myeloma by an on-body delivery system: results of a nurse survey.通过体内给药系统对多发性骨髓瘤患者皮下注射isatuximab：护士调查结果
Front Oncol. 2025 Jun 18;15:1547108. doi: 10.3389/fonc.2025.1547108. eCollection 2025.

本文引用的文献

1
A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting.医院环境中皮下注射与静脉注射肿瘤生物制剂的时间和资源使用成本的系统评价
Pharmacoecon Open. 2023 Jan;7(1):3-36. doi: 10.1007/s41669-022-00361-3. Epub 2022 Aug 23.
2
Anti-CD38 antibody therapy for patients with relapsed/refractory multiple myeloma: differential mechanisms of action and recent clinical trial outcomes.抗 CD38 抗体治疗复发/难治性多发性骨髓瘤患者：不同的作用机制和最近的临床试验结果。
Ann Hematol. 2022 Oct;101(10):2123-2137. doi: 10.1007/s00277-022-04917-5. Epub 2022 Aug 9.
3
Exposure-response analyses for selection/confirmation of optimal isatuximab dosing regimen in combination with pomalidomide/dexamethasone treatment in patients with multiple myeloma.
在多发性骨髓瘤患者中，与泊马度胺/地塞米松联合治疗时，进行暴露-反应分析以选择/确认伊沙妥昔单抗的最佳剂量方案。
CPT Pharmacometrics Syst Pharmacol. 2022 Jun;11(6):766-777. doi: 10.1002/psp4.12789. Epub 2022 Apr 17.
4
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): follow-up analysis of a randomised, phase 3 study.依沙佐米联合泊马度胺和低剂量地塞米松与泊马度胺和低剂量地塞米松治疗复发/难治性多发性骨髓瘤患者（ICARIA-MM）：一项随机、3 期研究的随访分析。
Lancet Oncol. 2022 Mar;23(3):416-427. doi: 10.1016/S1470-2045(22)00019-5. Epub 2022 Feb 10.
5
Diagnosis and Management of Multiple Myeloma: A Review.多发性骨髓瘤的诊断与治疗：综述
JAMA. 2022 Feb 1;327(5):464-477. doi: 10.1001/jama.2022.0003.
6
Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study.在人表皮生长因子受体 2（HER2）阳性早期乳腺癌（PHranceSCa）患者中，对曲妥珠单抗和帕妥珠单抗皮下注射固定剂量组合的偏好：一项随机、开放标签的 II 期研究。
Eur J Cancer. 2021 Jul;152:223-232. doi: 10.1016/j.ejca.2021.03.047. Epub 2021 Jun 16.
7
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial.isatuximab、卡非佐米和地塞米松用于复发多发性骨髓瘤（IKEMA）：一项多中心、开放标签、随机3期试验
Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.
8
Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results.接受皮下注射达雷妥尤单抗与静脉注射达雷妥尤单抗治疗复发或难治性多发性骨髓瘤的患者治疗满意度更高：COLUMBA 临床试验结果。
J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.
9
Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study.依沙佐米联合泊马度胺和低剂量地塞米松与泊马度胺和低剂量地塞米松治疗复发/难治性多发性骨髓瘤患者（ICARIA-MM）：一项随机、多中心、开放性、3 期研究。
Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14.
10
Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.生物制剂的皮下给药：当前挑战与机遇概述。
BioDrugs. 2018 Oct;32(5):425-440. doi: 10.1007/s40259-018-0295-0.