This study aimed to evaluate patients with RRMM who underwent daratumumab (DARA) therapy. This multicenter and retrospective study included 134 patients who underwent at least two courses of DARA from February 01, 2018 to April 15, 2022. Epidemiologic, disease and treatment characteristics of patients and, treatment related side effects were evaluated. Survival analysis were performed. The median age at initiation of DARA therapy was 60 (35-88) years. The median time to initiation of DARA and the median follow-up time were 41.2 (5.1-223) and 5.7 (2.1-24.1) months, respectively. The ORR after DARA therapy was 75 (55.9%), and ≥VGPR was observed in 48 (35.8%) patients. Overall survival (OS) and progression-free survival (PFS) for all patients were 11.6 (7.8-15.5) and 8.0 (5.1-10.9) months, respectively. OS was higher for patients undergoing DARA-Vd than for those undergoing DARA-Rd (16.9 vs. 8.3 months; p=0.014). Among patients undergoing Dara-Rd, PFS was higher in those without EMD (EMD-) than those with EMD (EMD+)(NA vs. 3.7 months; OR, 3.4; p < 0.001). The median number of prior therapies was 3 (1-8). Initiation of DARA therapy in the early period provides OS and PFS advantage, although statistically insignificant. Infusion-related reactions were observed in 18 (13.4%) patients. All reactions occurred during the first infusion and most reactions were grade 1-2 (94.5%). The frequency of neutropenia and thrombocytopenia was higher in the DARA-Rd group (61.9% vs. 24.7%; p < 0.001 and 42.9% vs. 15.7%; p < 0.001). Our study reflects real-life data in terms of DARA therapy for patients with RRMM and supports the early initiation of DARA therapy.

Multiple myeloma is the plasma cell malignancy in which bone involvement is common. The Fibroblast growth factor-23 (FGF-23)/Klotho pathway plays a major role in mineral metabolism that FGF-23 is mineralization inhibitory. Klotho also has anti-apoptotic and anti-tumor effects by acting as a tumor suppressor gene. There is a negative correlation between serum FGF-23 and serum soluble Klotho (sKL) levels. As such, there can be considerable interest in investigating sKL and FGF-23 as a biomarker in patients with MM. We used an enzyme-linked immunosorbent assay to measure serum FGF-23 and sKL levels in 55 newly diagnosed MM patients and 23 healthy controls. We determined significantly high serum FGF-23 and low serum sKL levels in MM patients when compared to healthy controls. Serum sKL levels correlated negatively with a p53 positive mutation status, with high ISS, elevated lactate dehydrogenase, C-reactive protein, Beta-2 microglobulin levels. Serum FGF-23 levels are associated negatively with serum phosphorus and positively only light chains and p53 mutation. Patients with high serum FGF-23 levels had significantly shorter median overall survival than those with low serum FGF-23 levels (p = 0.008). Additionally, low sKL levels were related to decreased overall survival, but they didn’t reach statistically significant (p = 0.072). There is a significant correlation between low serum sKL, high FGF-23 levels, and known prognostic factors in MM patients. We conclude that low sKL and high FGF-23 levels are a probable prognostic biomarker for poor MM patient outcomes.

Constantly increasing health expenditures lead use of generic molecules and generics of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects and reliability of generic bortezomib in newly diagnosed multiple myeloma (MM) patients. The data of 95 patients who received four cycles of bortezomib as a first- or second-line therapy in a single center were retrospectively recorded. Treatment responses, side effects and progression free survival (PFS) rates have been calculated and compared. Of the 95 patients, 42 used the original and 53 used the generic molecule. Epidemiological data, MM types, genetic risk groups, laboratory values at diagnosis and bortezomib treatment lines (as a first line or second) were evaluated, and there was no statistical difference between the two groups. When the response rates were evaluated with International Myeloma Working Group (IMWG) criteria, there were no significant difference (p: 0,42). Partial response (PR) and above response rates were similar (%81 vs %79,2 p:0,836). PFS values were 42.8 months in the original and 37.8 months in the generic molecule group (p: 0,68). Side effects were seen in 44,2% of patients, and the most common side effects were neuropathy, cytopenias and infections. They were similar in both groups (p: 0,67). Although this retrospective study is limited, it is the first study comparing the original molecule of bortezomib with its generic. There was no statistical difference between the two groups in terms of treatment responses, PFS times and side effects. However, large-scale evaluations can help obtain healthier data on this subject.