A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS

Case Report: Systemic amyloidosis results from the production of misfolded immunoglobulin light chains by monoclonal CD38+ plasma cells. These misfolded light chains form amyloid fibrils, which accumulate in various tissues and cause organ damage. Following the results of the Phase 3 ANDROMEDA study...

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Main Authors: Metban Mastanzade, Meryem Merve Ören Çelik, Simge Erdem, Mustafa Murat Özbalak, İpek Yönal Hindilerden, Mustafa Nuri Yenerel, Sevgi Kalayoğlu Beşışık
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:Hematology, Transfusion and Cell Therapy
Online Access:http://www.sciencedirect.com/science/article/pii/S2531137924028517
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author Metban Mastanzade
Meryem Merve Ören Çelik
Simge Erdem
Mustafa Murat Özbalak
İpek Yönal Hindilerden
Mustafa Nuri Yenerel
Sevgi Kalayoğlu Beşışık
author_facet Metban Mastanzade
Meryem Merve Ören Çelik
Simge Erdem
Mustafa Murat Özbalak
İpek Yönal Hindilerden
Mustafa Nuri Yenerel
Sevgi Kalayoğlu Beşışık
author_sort Metban Mastanzade
collection DOAJ
description Case Report: Systemic amyloidosis results from the production of misfolded immunoglobulin light chains by monoclonal CD38+ plasma cells. These misfolded light chains form amyloid fibrils, which accumulate in various tissues and cause organ damage. Following the results of the Phase 3 ANDROMEDA study, where the addition of daratumumab, an anti-CD38 agent, to first-line treatment showed favorable outcomes, Dara-VCD has become a standard first-line therapy. In this study, we compared the outcomes of patients with AL amyloidosis who were treated with first-line Dara-VCD in our clinic to those treated with other triplet regimens. Methodology: Patient's data with AL amyloidosis followed between 2010 and 2024 were retrospectively reviewed from the institution's database. Two groups were established patients treated with Dara-VCD and those without Dara. The clinical characteristics and response criteria were compared using SPSS 21. Results: A total of 52 patients were included in the study, with a mean age of 60 ± 10 years for the entire group. There was no statistically significant difference in the demographic distribution between the groups (p = 0.003). The median follow-up period was 32 months (1-114 months). In 27 (51.9%) patients, cardiac involvement was present, and 26 (50%) had renal involvement. The stages of these involvements are summarized in Table 1. In the group treated without Dara, the triplet regimens were VCD (n=30), VRD (n=3), and VMP (n=2).Mortality was significantly lower in the Dara-VCD group. When evaluating responses, progression was only in 1 (9%) patient in the Dara group, whereas in 8 (32%) in the without Dara group.The overall survival was not statistically significant between the two groups (log-rank p=0.394). (Figure 1). Conclusion: We used Dara after Health Authority approval and reimbursement in our country. So, we get the opportunity to compare Dara-added VCD effectiveness to VCD or VRD as a real-life analysis. Dara-VCD resulted in a significantly lower rate of progression and mortality compared to those without Dara. The follow-up duration was shorter for comment on overall survival. Additionally, 10 patients without the Dara group, did receive daratumumab with VCD (n=5), or with other agents (n=5)). With this study, we documented from a real-life experience addition of daratumumab to the VCD regimen in first-line treatment reduces mortality and progression in AL amyloidosis.
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spelling doaj-art-a0fc0bb411f44388a70dc4d57a4413692024-12-26T08:56:58ZengElsevierHematology, Transfusion and Cell Therapy2531-13792024-12-0146S26S27A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSISMetban Mastanzade0Meryem Merve Ören Çelik1Simge Erdem2Mustafa Murat Özbalak3İpek Yönal Hindilerden4Mustafa Nuri Yenerel5Sevgi Kalayoğlu Beşışık6Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Hematology; Corresponding author.Istanbul University, Istanbul Faculty of Medicine, Department of Public HealthIstanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of HematologyIstanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of HematologyIstanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of HematologyIstanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of HematologyIstanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of HematologyCase Report: Systemic amyloidosis results from the production of misfolded immunoglobulin light chains by monoclonal CD38+ plasma cells. These misfolded light chains form amyloid fibrils, which accumulate in various tissues and cause organ damage. Following the results of the Phase 3 ANDROMEDA study, where the addition of daratumumab, an anti-CD38 agent, to first-line treatment showed favorable outcomes, Dara-VCD has become a standard first-line therapy. In this study, we compared the outcomes of patients with AL amyloidosis who were treated with first-line Dara-VCD in our clinic to those treated with other triplet regimens. Methodology: Patient's data with AL amyloidosis followed between 2010 and 2024 were retrospectively reviewed from the institution's database. Two groups were established patients treated with Dara-VCD and those without Dara. The clinical characteristics and response criteria were compared using SPSS 21. Results: A total of 52 patients were included in the study, with a mean age of 60 ± 10 years for the entire group. There was no statistically significant difference in the demographic distribution between the groups (p = 0.003). The median follow-up period was 32 months (1-114 months). In 27 (51.9%) patients, cardiac involvement was present, and 26 (50%) had renal involvement. The stages of these involvements are summarized in Table 1. In the group treated without Dara, the triplet regimens were VCD (n=30), VRD (n=3), and VMP (n=2).Mortality was significantly lower in the Dara-VCD group. When evaluating responses, progression was only in 1 (9%) patient in the Dara group, whereas in 8 (32%) in the without Dara group.The overall survival was not statistically significant between the two groups (log-rank p=0.394). (Figure 1). Conclusion: We used Dara after Health Authority approval and reimbursement in our country. So, we get the opportunity to compare Dara-added VCD effectiveness to VCD or VRD as a real-life analysis. Dara-VCD resulted in a significantly lower rate of progression and mortality compared to those without Dara. The follow-up duration was shorter for comment on overall survival. Additionally, 10 patients without the Dara group, did receive daratumumab with VCD (n=5), or with other agents (n=5)). With this study, we documented from a real-life experience addition of daratumumab to the VCD regimen in first-line treatment reduces mortality and progression in AL amyloidosis.http://www.sciencedirect.com/science/article/pii/S2531137924028517
spellingShingle Metban Mastanzade
Meryem Merve Ören Çelik
Simge Erdem
Mustafa Murat Özbalak
İpek Yönal Hindilerden
Mustafa Nuri Yenerel
Sevgi Kalayoğlu Beşışık
A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
Hematology, Transfusion and Cell Therapy
title A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
title_full A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
title_fullStr A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
title_full_unstemmed A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
title_short A SINGLE-CENTER REAL-LIFE EXPERIENCE WITH FIRST-LINE DARATUMUMAB, BORTEZOMIB, CYCLOPHOSPHAMIDE, AND DEXAMETHASONE (DARA-VCD) IN AL AMYLOIDOSIS
title_sort single center real life experience with first line daratumumab bortezomib cyclophosphamide and dexamethasone dara vcd in al amyloidosis
url http://www.sciencedirect.com/science/article/pii/S2531137924028517
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