TY - JOUR
T1 - Comparable outcomes using propylene glycol-free melphalan for autologous stem cell transplantation in multiple myeloma
AU - Miller, Kevin C.
AU - Gertz, Morie A.
AU - Buadi, Francis K.
AU - Hayman, Suzanne R.
AU - Wolf, Robert C.
AU - Lacy, Martha Q.
AU - Dispenzieri, Angela A.
AU - Dingli, David
AU - Kapoor, Prashant
AU - Gonsalves, Wilson I.
AU - Kourelis, Taxiarchis
AU - Hogan, William J.
AU - Kumar, Shaji K.
N1 - Funding Information:
Acknowledgements SKK is supported in part by US National Cancer Institute grants CA 107476, CA 168762, and CA186781.
Publisher Copyright:
© 2018, Springer Nature Limited.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - 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.
AB - 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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U2 - 10.1038/s41409-018-0302-6
DO - 10.1038/s41409-018-0302-6
M3 - Article
C2 - 30116014
AN - SCOPUS:85052541725
SN - 0268-3369
VL - 54
SP - 587
EP - 594
JO - Bone Marrow Transplantation
JF - Bone Marrow Transplantation
IS - 4
ER -