Frontiers in medicine · 2025
A real-world data study of the effect of co-solvent differences on the clinical safety of melphalan for injection.
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Wang Guorong, Chen Wenming, Zuo Chenwei, Li Huang, Yan Jianzhou
Аннотация
OBJECTIVE: This study aimed to compare the efficacy and safety of myeloablative conditioning with high-dose propylene glycol-free melphalan (PGF-Mel, EVOMELA®) versus propylene glycol melphalan (PG-Mel) in Chinese patients with multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT) in the real world.
METHODS: This is a single-center, retrospective study of 107 patients with MM. Patients were divided into two groups based on their high-dose myeloablative conditioning regimen before autologous stem cell transplantation (ASCT): the EVOMELA® group (53 patients) and the PG-Mel group (54 patients). Qualitative data were compared using the two independent samples t-test and two independent samples Mann-Whitney U-test, and quantitative data were compared using the chi-square test. Efficacy and safety parameters were assessed and compared between the two groups.
RESULTS: The median time to myeloablation, the median time to platelet engraftment, and the neutrophil nadir were significantly lower in the EVOMELA® group than in the PG-Mel group (p < 0.05). In contrast, the median time to neutrophil engraftment, the lymphocyte nadir, and the number of platelet transfusions did not differ significantly between the two groups (p > 0.05). Adverse events, such as ionic disorders (hypokalemia, hypocalcemia, hypophosphatemia), nausea, diarrhea, vomiting, and loss of appetite, are significantly lower in the EVOMELA® group than in the PG-Mel group (p < 0.05), and the incidence of pyrexia between the two groups is not statistically different (p > 0.05). The average length of a hospitalization stay between the two groups was similar (p > 0.05). The EVOMELA® group had a higher CR rate (73.6% vs. 38.9%) and a lower PR rate (3.8% vs. 13.0%) than the PG-Mel group, indicating superior post-transplantation response outcomes for EVOMELA®. Median progression-free survival was 51.4 months (95% confidence interval (CI) 43.5-59.2) in the EVOMELA® group and 49.0 months (95% CI 39.7-58.3) (p = 0.115) in the PG-Mel group (HR 0.76, 95% CI 0.49-1.08; p = 0.116). Median overall survival was 56.2 months (95% CI 51.3-61.1) in the EVOMELA® group and 57.9 months (95% CI 53.5-62.4) (p = 0.007) in the PG-Mel group (HR 0.57, 95% CI 0.37-0.86; p = 0.008). The EVOMELA® group had a higher rate of minimal residual disease (MRD) negativity after ASCT (73.6% vs. 48.1%, p = 0.007) than the PG-Mel group.
CONCLUSION: EVOMELA® appears to demonstrate better efficacy and safety compared to PG-Mel; nonetheless, considering the study's limitations, these observations warrant further rigorous investigation to confirm their validity.
METHODS: This is a single-center, retrospective study of 107 patients with MM. Patients were divided into two groups based on their high-dose myeloablative conditioning regimen before autologous stem cell transplantation (ASCT): the EVOMELA® group (53 patients) and the PG-Mel group (54 patients). Qualitative data were compared using the two independent samples t-test and two independent samples Mann-Whitney U-test, and quantitative data were compared using the chi-square test. Efficacy and safety parameters were assessed and compared between the two groups.
RESULTS: The median time to myeloablation, the median time to platelet engraftment, and the neutrophil nadir were significantly lower in the EVOMELA® group than in the PG-Mel group (p < 0.05). In contrast, the median time to neutrophil engraftment, the lymphocyte nadir, and the number of platelet transfusions did not differ significantly between the two groups (p > 0.05). Adverse events, such as ionic disorders (hypokalemia, hypocalcemia, hypophosphatemia), nausea, diarrhea, vomiting, and loss of appetite, are significantly lower in the EVOMELA® group than in the PG-Mel group (p < 0.05), and the incidence of pyrexia between the two groups is not statistically different (p > 0.05). The average length of a hospitalization stay between the two groups was similar (p > 0.05). The EVOMELA® group had a higher CR rate (73.6% vs. 38.9%) and a lower PR rate (3.8% vs. 13.0%) than the PG-Mel group, indicating superior post-transplantation response outcomes for EVOMELA®. Median progression-free survival was 51.4 months (95% confidence interval (CI) 43.5-59.2) in the EVOMELA® group and 49.0 months (95% CI 39.7-58.3) (p = 0.115) in the PG-Mel group (HR 0.76, 95% CI 0.49-1.08; p = 0.116). Median overall survival was 56.2 months (95% CI 51.3-61.1) in the EVOMELA® group and 57.9 months (95% CI 53.5-62.4) (p = 0.007) in the PG-Mel group (HR 0.57, 95% CI 0.37-0.86; p = 0.008). The EVOMELA® group had a higher rate of minimal residual disease (MRD) negativity after ASCT (73.6% vs. 48.1%, p = 0.007) than the PG-Mel group.
CONCLUSION: EVOMELA® appears to demonstrate better efficacy and safety compared to PG-Mel; nonetheless, considering the study's limitations, these observations warrant further rigorous investigation to confirm their validity.