Original vs. Generic Plerixafor for the Mobilization of Stem Cells in Multiple Myeloma Patients

原研药与仿制药普乐沙福在多发性骨髓瘤患者干细胞动员中的比较

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Abstract

This study investigates the efficacy and safety of generic plerixafor (Pleksor - Gen Pharma) compared to the original plerixafor (Mozobil - Sanofi) in patients with multiple myeloma undergoing ASCT. A total of 59 patients from three centers, who underwent ASCT between 2018 and 2023, were included and divided into two groups: Mozobil (M) group (n = 32) and Pleksor (P) group (n = 27). Plerixafor was administered as a just-in-time approach with granulocyte-colony stimulating factor (G-CSF) alone or with cyclophosphamide (Cy) + G-CSF mobilization. The study aimed to assess mobilization success and engraftment kinetics. There was no statistically significant difference between the two groups in terms of age, gender, RT history, previous lines of treatment, pretransplant lenalidomide cycles (p = 0.778, 0.165, 0.520, 0.094, 0.530, respectively). However, lenalidomide exposure was significantly higher in P group (18,8% vs. 81,5%, p < 0.001). Both groups achieved a similar total yield of CD34 + cells, and no serious side effects related to plerixafor were noted. Median platelet engraftment time was longer in P group, while neutrophil engraftment time was similar in both groups. This study demonstrates the comparable efficacy of generic plerixafor in myeloma patients, suggesting that it can be a cost-effective alternative with a similar safety profile. These findings contribute to the body of evidence on the use of generic plerixafor in specific patient cohorts, emphasizing its efficacy and safety for ASCT in a sole multiple myeloma patient cohort.

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