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Comparable outcomes using propylene glycol-free melphalan for autologous stem cell transplantation in multiple myeloma

Abstract

Autologous stem cell transplantation (ASCT) remains a mainstay in the treatment of multiple myeloma (MM). While the procedure is generally safe, toxicities associated with high-dose melphalan conditioning are common and significantly affect patient quality of life. Recently, a propylene glycol-free melphalan formulation (PG-free MEL; Evomela®) was approved by the United States Food and Drug Administration as an ASCT-conditioning regimen for MM. PG-free MEL is more soluble and stable than propylene glycol-solubilized melphalan (PG-solubilized MEL; Alkeran®). As such, there is speculation that it could decrease toxicities and increase the efficacy of ASCT. We compared the outcomes of patients conditioned with PG-free MEL (n = 216) to PG-solubilized MEL (n = 200) at our institution. The baseline characteristics were similar between the two groups. After Day +0, there were no differences in terms of hospitalizations, neutropenic fevers, intravenous granisetron requirement, World Health Organization grade ≥ 2 oral/esophageal mucositis, intravenous fluid requirement, or narcotic requirement. However, PG-free MEL patients had a higher incidence of diarrhea, which was mostly C. difficile-negative (82% vs. 71%, P = 0.015*). Day + 100 hematologic responses and progression-free survival after ASCT were comparable. In summary, we demonstrate that switching to PG-free MEL did not significantly reduce short-term complications of ASCT or improve outcomes in MM.

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Additional information

Parts of this manuscript were presented in abstract form at the 23rd European Hematology Association Congress in Stockholm, Sweden on 17 June 2018.

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Acknowledgements

SKK is supported in part by US National Cancer Institute grants CA 107476, CA 168762, and CA186781.

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Conflict of interest

SKK has been a non-paid consultant or advisory board member for AbbVie, Celgene, Janssen, Kite Pharma, Merck, and Takeda and is the principal investigator in clinical trials supported by Bristol-Myers Squibb, Celgene, Janssen, Kite Pharma, Roche/Genentech, Sanofi, and Takeda.

Correspondence to Shaji K. Kumar.

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