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Pharmacokinetics and Efficacy of Generic Melphalan Is Comparable to Innovator Formulation in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation
A.A. Pai, A.J. Devasia, J.C. Panetta, S. Mani, R.S. Stallon Illangeswaran, E. Mohanan, , K.M. Lakshmi, U. Kulkarni, F.N. AboobackerShow More
Published in Elsevier Inc.
2020
PMID: 31791694
Volume: 20
   
Issue: 2
Pages: 130 - 135.e1
Abstract
Background: High-dose melphalan (MEL) is the standard conditioning regimen used for autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM). Generic MEL is routinely used in various transplant centers across the world including ours due to its reduced cost and ease of availability. We compared the pharmacokinetics (PK) and the clinical efficacy of generic MEL with that of the innovator formulation in MM patients undergoing ASCT. Patients and Methods: Sixty-three patients diagnosed with MM receiving high-dose MEL were included in this study. MEL levels in plasma were measured using a liquid chromatography tandem mass spectrometry (HPLC/MS-MS) protocol and non-linear mixed effects modeling was used to evaluate the PK of the data. Results: The interindividual variability (IIV) in MEL area under the concentration versus time curve (AUC) and clearance (CL) were 4.39, 5.88-fold for generic, and 4.34, 6.85-fold for the innovator formulation, respectively. The median MEL AUC and CL were comparable between the 2 formulations. The population PK analysis showed age and creatinine CL as the only significant covariates explaining IIV in MEL AUC/CL. Analysis of MEL PK parameters with clinical outcome showed no significant differences in terms of onset and severity of mucositis, day to neutrophil and platelet engraftment, as well as response status on day 100 post ASCT between patients receiving generic or innovator formulations of MEL. In addition, neither MEL AUC nor CL was found to be associated with day +100 response. Conclusion: Our study suggests that the PK and efficacy of the generic MEL is comparable to the innovator formulation. © 2019 Elsevier Inc. Pharmacokinetics and therapeutic efficacy were investigated in patients with multiple myeloma receiving both generic and innovator melphalan (MEL) formulation for conditioning pre autologous stem cell transplantation. Both the MEL formulations were comparable in terms of pharmacokinetics and efficacy, suggesting generic MEL as a low-cost alternative to innovator MEL for autologous stem cell transplantation conditioning in multiple myeloma. © 2019 Elsevier Inc.
About the journal
JournalData powered by TypesetClinical Lymphoma, Myeloma and Leukemia
PublisherData powered by TypesetElsevier Inc.
ISSN21522650