Real World Data of Daratumumab Treatment in Patient with Multiple Myeloma: A Portuguese Study

OBJECTIVES: Multiple Myeloma (MM) is an incurable disease and the second most common hematologic malignancy. Treatment of MM has evolved in the past few years with availability of several news drugs as well as increasing use of multidrug combinations. Monoclonal antibody targeting CD38, daratumumab, has been shown to be a game changer. Major trials have proven benefits in both progression free survival (PFS) and response rate in favor of daratumumab incorporation into doublet regimen. Hereby, the aim of this study was retrospectively evaluate the efficacy and safety profile of Daratumumab in MM patients, to obtain a real-world assessment of their outcomes.

METHODS: This two-center retrospective study includes six patients diagnosed with MM who underwent treatment with Daratumumab in monotherapy or in combination between 2019-2023. Demographic data and medical history, MM characteristics, treatment regimen, measures of efficacy and treatment safety profile were evaluated. All data were analyzed using descriptive statistical methodologies.

RESULTS: The clinical data of six patients were included with a median age of 75 years (83% were over 65 years). The median number of previous treatment lines was 2 and 1 patient presented high-risk features. Most patients were treated with Daratumumab with dexamethasone (50%), the combination with bortezomib, lenalidomide and dexamethasone (DVRd) was administered in 2 patients and with bortezomib, melphalan and prednisone (DVMP) in 1 patient. The overall response rate was 84% with 17% achieving CR, 50% VGPR, 17% PR and progressive disease in 16%. With a median follow-up of 7 months (4-52 months), the median of PFS and OS were not reached in five patients who are still undergoing treatment. Regarding to safety profile, side effects were reported in 2 patients (infusion reactions (grade 2) and diarrhea).

CONCLUSIONS: This real-life study demonstrated that Daratumumab regimens are effective, allowing deep and prolonged responses with an acceptable safety profile.