Efficacy and Safety of Daratumumab, Lenalidomide and Dexamethasone Therapy in the First Relapse of Multiple Myeloma Patients - Real World Data from Hungary

Q: What was the main goal of this real-world study?

To evaluate the effectiveness and safety of the daratumumab–lenalidomide–dexamethasone (D-Rd) regimen as second-line therapy in routine clinical care for patients at first relapse of multiple myeloma.

Q: How many patients received D-Rd and when was treatment given?

Fifty-five Hungarian patients with multiple myeloma were enrolled and received D-Rd at first relapse through a reimbursement program between February 2022 and August 2023.

Q: Which factors were associated with poorer survival outcomes?

Advanced disease stage, high-risk cytogenetic abnormalities, and frailty were linked to significantly worse progression-free survival and overall survival, whereas prior autologous stem cell transplantation and lenalidomide maintenance were not significantly associated with survival.

Q: What safety outcomes were observed during the study period?

Three deaths due to severe infections occurred. The most common adverse events were mild hematologic toxicities and injection-related reactions.

Sep 28, 2026

Uploaded by Bulrr

Background: Daratumumab is a monoclonal antibody targeting CD38 with demonstrated activity in newly diagnosed and relapsed/refractory multiple myeloma. This study evaluated the effectiveness and safety of the daratumumab–lenalidomide–dexamethasone (D-Rd) regimen as second-line therapy in routine clinical practice. Methods: Fifty-five Hungarian multiple myeloma patients received D-Rd at first relapse via a reimbursement program from February 2022 to August 2023, with responses, PFS, OS, and safety outcomes collected systematically. Results: Response occurred in 49 patients (89%); after a median follow-up of 36.6 months, median PFS was 22.0 months and median OS was not reached. Advanced stage, high-risk cytogenetics, and frailty predicted worse outcomes, while prior autologous transplant and lenalidomide maintenance did not significantly affect survival. Three deaths due to severe infections were reported; common adverse events were mild hematologic toxicities and injection-related reactions. Conclusions: Findings support D-Rd as an effective option for first relapse, though survival was less favorable than pivotal trial results.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Background

Methods

Results

Treatment response and survival

Prognostic factors and prior therapies

Safety outcomes

Conclusions

Keywords

Original Article J Hematol. 2025;14(6):314-323 Efficacy and Safety of Daratumumab, Lenalidomide and Dexamethasone Therapy in the First Relapse of Multiple Myeloma Patients – Real World Data from Hungary Szilvia Lovasa, b, Nora Obajed Al-Alia, b, Katalin Farkasa, b, Laszlo Imre Pinczesa, b, Gergely Vargac, Gabor Mikalac, Peter Rajnicsd, Szabolcs Kosztolanyie, Mark Planderf, Piroska Pettendig, Laszlo Varoczya, b, h Abstract Background: Daratumumab is a monoclonal antibody targeting CD38, which has demonstrated efficacy in both newly diagnosed andrelapsed or refractory multiple myeloma (MM) . The objective of our study was to evaluate the effectiveness and safety of the daratumumab, lenalidomide, and dexamethasone (D-Rd) regimen as a secondline therapy in a real-world clinical setting. Methods: A total of 55 Hungarian patients with MM were enrolled, all of whom received D-Rd at first relapse through a special reimbursement program between February 2022 and August 2023. Treatment responses, progression-free survival (PFS), and overall survival (OS) were assessed in the intent-to-treat population as well as in selected subgroups. Safety outcomes were also systematically collected. Results: Treatment response was observed in 49 patients (89%), with 12 complete responses, 22 very good partial responses, and 15 partial responses. After a median follow-up of 36.6 months, the median PFS for the entire cohort was 22.0 months, while median OS had not been reached yet. Patients with advanced-stage disease (Revised International Manuscript submitted October 8, 2025, accepted November 21, 2025 Published online December 30, 2025 aDepartment of Hematology, Institute for Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary bDoctoral School of Clinical Sciences, University of Debrecen, Debrecen, Hungary cDepartment of Medicine and Hematology, Faculty of Medicine, Semmelweis University, Budapest, Hungary dDepartment of Hematology, Mor Kaposi Hospital, Kaposvar, Hungary e 1st Department of Medicine, Faculty of Medicine, University of Pecs, Pecs, Hungary fDepartment of Hematology and Hemostasis, Markusovszky Hospital, Szombathely, Hungary g 1st Department of Medicine, Geza Hetenyi Hospital, Szolnok, Hungary hCorresponding Author: Laszlo Varoczy, Department of Hematology, Institute for Medicine, University of Debrecen, H-4032 Debrecen, Hungary. [Email: varoczy@internal.med.unideb.hu](Email: varoczy@internal.med.unideb.hu) doi: [https://doi.org/10.14740/jh2142](https://doi.org/10.14740/jh2142) Staging System stage 3) showed significantly poorer survival outcomes compared with those in stage 1 or 2 (PFS: P < 0.001; OS: P = 0.015) . High-risk cytogenetic abnormalities and frailty were also associated with markedly inferior prognosis. In contrast, neither prior autologous stem cell transplantation nor lenalidomide maintenance therapy had a significant impact on survival. During the study period, three deaths due to severe infections occurred, while the most common adverse events were mild hematologic toxicities and injection-related reactions. Conclusions: Our findings support the use of D-Rd as an effective option for first relapse in MM patients. However, our survival data are inferior to the results of the pivotal studies targeting the same population. Keywords: Multiple myeloma; Daratumumab; Lenalidomide; Treatment response; Progression-free survival; Overal survival; Frailty Introduction Multiple myeloma (MM) is a type of lymphoproliferative disorder representing approximately 1% of all malignancies. It involves the uncontrolled growth of abnormal plasma cells, leading to complications such as bone destruction, elevated calcium levels, bone marrow failure, and kidney dysfunction. Although currently considered incurable, recent advances in treatment options have significantly improved patient survival rates [1] . In newly diagnosed MM, recently published guidelines recommend the use of qu

FAQs

What was the main goal of this real-world study?

To evaluate the effectiveness and safety of the daratumumab–lenalidomide–dexamethasone (D-Rd) regimen as second-line therapy in routine clinical care for patients at first relapse of multiple myeloma.

How many patients received D-Rd and when was treatment given?

Fifty-five Hungarian patients with multiple myeloma were enrolled and received D-Rd at first relapse through a reimbursement program between February 2022 and August 2023.

Which factors were associated with poorer survival outcomes?

Advanced disease stage, high-risk cytogenetic abnormalities, and frailty were linked to significantly worse progression-free survival and overall survival, whereas prior autologous stem cell transplantation and lenalidomide maintenance were not significantly associated with survival.

What safety outcomes were observed during the study period?

Three deaths due to severe infections occurred. The most common adverse events were mild hematologic toxicities and injection-related reactions.

Sep 28, 2026

Uploaded by Bulrr