{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:03:55Z","timestamp":1758931435759,"version":"3.44.0"},"reference-count":25,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T00:00:00Z","timestamp":1758844800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>This study aimed to compare the efficacy and safety of myeloablative conditioning with high-dose propylene glycol-free melphalan (PGF-Mel, EVOMELA<jats:sup>\u00ae<\/jats:sup>) versus propylene glycol melphalan (PG-Mel) in Chinese patients with multiple myeloma (MM) undergoing autologous stem cell transplantation (ASCT) in the real world.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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<jats:sup>\u00ae<\/jats:sup> 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\u2013Whitney U-test, and quantitative data were compared using the chi-square test. Efficacy and safety parameters were assessed and compared between the two groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The median time to myeloablation, the median time to platelet engraftment, and the neutrophil nadir were significantly lower in the EVOMELA<jats:sup>\u00ae<\/jats:sup> group than in the PG-Mel group (<jats:italic>p<\/jats:italic>\u202f&amp;lt;\u202f0.05). 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 (<jats:italic>p<\/jats:italic>\u202f&amp;gt;\u202f0.05). Adverse events, such as ionic disorders (hypokalemia, hypocalcemia, hypophosphatemia), nausea, diarrhea, vomiting, and loss of appetite, are significantly lower in the EVOMELA<jats:sup>\u00ae<\/jats:sup> group than in the PG-Mel group (<jats:italic>p<\/jats:italic>\u202f&amp;lt;\u202f0.05), and the incidence of pyrexia between the two groups is not statistically different (<jats:italic>p<\/jats:italic>\u202f&amp;gt;\u202f0.05). The average length of a hospitalization stay between the two groups was similar (<jats:italic>p<\/jats:italic>\u202f&amp;gt;\u202f0.05). The EVOMELA<jats:sup>\u00ae<\/jats:sup> 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<jats:sup>\u00ae<\/jats:sup>. Median progression-free survival was 51.4\u202fmonths (95% confidence interval (CI) 43.5\u201359.2) in the EVOMELA<jats:sup>\u00ae<\/jats:sup> group and 49.0\u202fmonths (95% CI 39.7\u201358.3) (<jats:italic>p<\/jats:italic>\u202f=\u202f0.115) in the PG-Mel group (HR 0.76, 95% CI 0.49\u20131.08; <jats:italic>p<\/jats:italic>\u202f=\u202f0.116). Median overall survival was 56.2\u202fmonths (95% CI 51.3\u201361.1) in the EVOMELA<jats:sup>\u00ae<\/jats:sup> group and 57.9\u202fmonths (95% CI 53.5\u201362.4) (<jats:italic>p<\/jats:italic>\u202f=\u202f0.007) in the PG-Mel group (HR 0.57, 95% CI 0.37\u20130.86; <jats:italic>p<\/jats:italic>\u202f=\u202f0.008). The EVOMELA<jats:sup>\u00ae<\/jats:sup> group had a higher rate of minimal residual disease (MRD) negativity after ASCT (73.6% vs. 48.1%, <jats:italic>p<\/jats:italic>\u202f=\u202f0.007) than the PG-Mel group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>EVOMELA<jats:sup>\u00ae<\/jats:sup> appears to demonstrate better efficacy and safety compared to PG-Mel; nonetheless, considering the study\u2019s limitations, these observations warrant further rigorous investigation to confirm their validity.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fmed.2025.1554818","type":"journal-article","created":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T05:31:49Z","timestamp":1758864709000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A real-world data study of the effect of co-solvent differences on the clinical safety of melphalan for 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