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

Szilvia Lovas, Gergely Varga, Péter Farkas, T. Masszi, Nikolett Wohner, Ágnes Bereczki, Nóra Adamkovich, Zita Borbényi, Árpád Szomor, Hussain Alizadeh, Erika Szaleczky, Krisztina Wolf, Tamás Schneider, Márk Plander, Tamás Szendrei, Ottó Csacsovszki, Zoltán Csukly, Péter Rajnics, Miklós Egyed, Zsolt NagyLászló Rejtő, A. Illés, G. Mikala, László Váróczy

Research output: Article

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.

Original languageEnglish
JournalInternational Journal of Hematology
DOIs
Publication statusPublished - jan. 1 2019

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Multiple Myeloma
Safety
Disease-Free Survival
Kidney
Therapeutics
daratumumab
Monoclonal Antibodies
Survival
Infection

ASJC Scopus subject areas

  • Hematology

Cite this

Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients. / Lovas, Szilvia; Varga, Gergely; Farkas, Péter; Masszi, T.; Wohner, Nikolett; Bereczki, Ágnes; Adamkovich, Nóra; Borbényi, Zita; Szomor, Árpád; Alizadeh, Hussain; Szaleczky, Erika; Wolf, Krisztina; Schneider, Tamás; Plander, Márk; Szendrei, Tamás; Csacsovszki, Ottó; Csukly, Zoltán; Rajnics, Péter; Egyed, Miklós; Nagy, Zsolt; Rejtő, László; Illés, A.; Mikala, G.; Váróczy, László.

In: International Journal of Hematology, 01.01.2019.

Research output: Article

Lovas, S, Varga, G, Farkas, P, Masszi, T, Wohner, N, Bereczki, Á, Adamkovich, N, Borbényi, Z, Szomor, Á, Alizadeh, H, Szaleczky, E, Wolf, K, Schneider, T, Plander, M, Szendrei, T, Csacsovszki, O, Csukly, Z, Rajnics, P, Egyed, M, Nagy, Z, Rejtő, L, Illés, A, Mikala, G & Váróczy, L 2019, 'Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients', International Journal of Hematology. https://doi.org/10.1007/s12185-019-02715-w
Lovas, Szilvia ; Varga, Gergely ; Farkas, Péter ; Masszi, T. ; Wohner, Nikolett ; Bereczki, Ágnes ; Adamkovich, Nóra ; Borbényi, Zita ; Szomor, Árpád ; Alizadeh, Hussain ; Szaleczky, Erika ; Wolf, Krisztina ; Schneider, Tamás ; Plander, Márk ; Szendrei, Tamás ; Csacsovszki, Ottó ; Csukly, Zoltán ; Rajnics, Péter ; Egyed, Miklós ; Nagy, Zsolt ; Rejtő, László ; Illés, A. ; Mikala, G. ; Váróczy, László. / Real-world data on the efficacy and safety of daratumumab treatment in Hungarian relapsed/refractory multiple myeloma patients. In: International Journal of Hematology. 2019.
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AU - Lovas, Szilvia

AU - Varga, Gergely

AU - Farkas, Péter

AU - Masszi, T.

AU - Wohner, Nikolett

AU - Bereczki, Ágnes

AU - Adamkovich, Nóra

AU - Borbényi, Zita

AU - Szomor, Árpád

AU - Alizadeh, Hussain

AU - Szaleczky, Erika

AU - Wolf, Krisztina

AU - Schneider, Tamás

AU - Plander, Márk

AU - Szendrei, Tamás

AU - Csacsovszki, Ottó

AU - Csukly, Zoltán

AU - Rajnics, Péter

AU - Egyed, Miklós

AU - Nagy, Zsolt

AU - Rejtő, László

AU - Illés, A.

AU - Mikala, G.

AU - Váróczy, László

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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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KW - Multiple myeloma

KW - Survival

KW - Toxicity

KW - Treatment response

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