International Journal of Hematology

DOI: 10.1007/s12185-019-02715-w Pages: 559-565

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

1. University of Debrecen, Department of Hematology, Institute for Medicine, Faculty of Medicine

2. Semmelweis University, 3rd Department of Internal Medicine

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

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

5. National Institute of Oncology

6. Markusovszky Teaching Hospital, Department of Hematology

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

8. Mór Kaposi Teaching Hospital, Department of Hematology

9. Semmelweis University, 1st Department of Internal Medicine

10. Jósa András Teaching Hospital, Department of Hematology

Correspondence to:
László Váróczy
Tel: 36-52-255112
Email: varoczy@internal.med.unideb.hu

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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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