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Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients

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Abstract

Daratumumab is a human anti-CD38 monoclonal antibody used in the treatment of refractory and relapsed multiple myeloma. We investigated the efficacy and safety of daratumumab therapy in a real-world setting. Ninety-nine Hungarian patients were included; 48 received monotherapy, while lenalidomide and bortezomib combinations were administered in 29 and 19 cases, respectively. Overall response rate was assessable in 88 patients, with 12 complete, 10 very good partial, 34 partial, and seven minor responses. At a median duration of follow-up of 18.6 months, median progression-free survival (PFS) among all patients was 17.0 months. These values were inferior in the bortezomib combination and monotherapy groups. Patients with early-stage disease (ISS1) had better survival results than those with stage 2 or 3 myeloma (p = 0.009). Heavily pretreated patients had inferior PFS compared to those with 1–3 therapies (p = 0.035). Patients with impaired renal function had PFS results comparable with those having no kidney involvement. There were 10 fatal infections, and the most frequent adverse events were mild infusion-associated reactions and hematologic toxicities. Our results confirm that daratumumab is an effective treatment option for relapsed/refractory MM with an acceptable safety profile in patients with normal and impaired renal function.

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Author notes

  1. Gábor Mikala and László Váróczy equally contributed to this work.

Authors and Affiliations

  1. Department of Hematology, Institute for Medicine, Faculty of Medicine, University of Debrecen, Nagyerdei krt. 98., 4032, Debrecen, Hungary

    Szilvia Lovas, Árpád Illés & László Váróczy

  2. 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary

    Gergely Varga, Péter Farkas, Tamás Masszi & Nikolett Wohner

  3. 2nd Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged, Szeged, Hungary

    Ágnes Bereczki, Nóra Adamkovich & Zita Borbényi

  4. 1st Department of Internal Medicine, University of Pécs, Pecs, Hungary

    Árpád Szomor & Hussain Alizadeh

  5. National Institute of Oncology, Budapest, Hungary

    Erika Szaleczky, Krisztina Wolf & Tamás Schneider

  6. Department of Hematology, Markusovszky Teaching Hospital, Szombathely, Hungary

    Márk Plander & Tamás Szendrei

  7. Department of Hematology and Stem Cell Transplantation, South-Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary

    Ottó Csacsovszki, Zoltán Csukly & Gábor Mikala

  8. Department of Hematology, Mór Kaposi Teaching Hospital, Kaposvár, Hungary

    Péter Rajnics & Miklós Egyed

  9. 1st Department of Internal Medicine, Semmelweis University, Budapest, Hungary

    Zsolt Nagy

  10. Department of Hematology, Jósa András Teaching Hospital, Nyíregyháza, Hungary

    László Rejtő

Authors
  1. Szilvia Lovas
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  2. Gergely Varga
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  4. Tamás Masszi
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  5. Nikolett Wohner
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  6. Ágnes Bereczki
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  7. Nóra Adamkovich
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  8. Zita Borbényi
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  9. Árpád Szomor
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  10. Hussain Alizadeh
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  11. Erika Szaleczky
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  12. Krisztina Wolf
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  13. Tamás Schneider
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  14. Márk Plander
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  15. Tamás Szendrei
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  16. Ottó Csacsovszki
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  17. Zoltán Csukly
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  18. Péter Rajnics
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  19. Miklós Egyed
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  20. Zsolt Nagy
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  21. László Rejtő
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  22. Árpád Illés
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  23. Gábor Mikala
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  24. László Váróczy
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Correspondence to László Váróczy.

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Lovas, S., Varga, G., Farkas, P. et al. Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients. Int J Hematol 110, 559–565 (2019). https://doi.org/10.1007/s12185-019-02715-w

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  • DOI: https://doi.org/10.1007/s12185-019-02715-w

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