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Evaluating the adverse effects of melphalan formulations

Published on Oct 1, 2019in Journal of Oncology Pharmacy Practice1.826
· DOI :10.1177/1078155218804042
Elaine Xiang (Harvard University), Jian Ni (Brigham and Women's Hospital)+ 3 AuthorsAnne M. McDonnell8
Estimated H-index: 8
(Brigham and Women's Hospital)
Abstract
IntroductionFor multiple myeloma patients who respond to primary therapy, autologous hematopoietic stem cell transplant (HSCT) is considered standard of care with high-dose melphalan for transplant candidates. There are now two different melphalan formulations available, including a propylene glycol containing (PG-MEL) product and a propylene glycol-free (PG-free MEL) product. Although considered bioequivalent, there remains limited literature directly evaluating the adverse events between the two agents. We seek to assess the tolerability and severity of side effects between the two formulations in a real-life practice setting.MethodsA retrospective, descriptive analysis was conducted of multiple myeloma patients who received autologous stem cell conditioning with either melphalan formulation when dosed at 100 mg/m2/dose for two consecutive doses. The primary outcome was the assessment of tolerability and severity of side effects. Tolerability was split into four major categories including hematologic to...
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References15
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#1Rebecca L. Siegel (ACS: American Cancer Society)H-Index: 47
#2Kimberly D. Miller Mph (ACS: American Cancer Society)H-Index: 2
Last. Ahmedin Jemal Dvm (ACS: American Cancer Society)H-Index: 4
view all 3 authors...
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on cancer incidence, mortality, and survival. Incidence data, available through 2014, were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data, available through 2015, were collected by the Nation...
3,124 CitationsSource
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on cancer incidence, mortality, and survival. Incidence data, available through 2014, were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data, available through 2015, were collected by the Nation...
4,299 CitationsSource
#1Gunjan L. Shah (Cornell University)H-Index: 9
#2Heather Landau (Cornell University)H-Index: 19
Last. Sergio A. Giralt (Cornell University)H-Index: 40
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Background: Melphalan exposure as measured by area under the curve (AUC) has a 5-fold variability between patients, with higher AUCs associated with improved outcomes but increased toxicity (Shaw BBMT 2012). Propylene glycol free melphalan (Evomela®, PGF-MEL) is an intravenous formulation with improved stability and possibly less toxicity related to the solubilizing agent. We have switched to PGF-MEL as conditioning prior to AHCT for multiple myeloma (MM) and AL amyloidosis (AL) and aimed to det...
1 Citations
BackgroundHigh-dose chemotherapy plus autologous stem-cell transplantation has been the standard treatment for newly diagnosed multiple myeloma in adults up to 65 years of age. However, promising data on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone (RVD) in this population have raised questions about the role and timing of transplantation. MethodsWe randomly assigned 700 patients with multiple myeloma to receive induction therapy with three cycles of RVD and th...
218 CitationsSource
#1Parameswaran Hari (MCW: Medical College of Wisconsin)H-Index: 41
#2Omar S. Aljitawi (KU: University of Kansas)H-Index: 12
Last. Keith Stockerl-Goldstein (WashU: Washington University in St. Louis)H-Index: 34
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Abstract Autologous stem cell transplantation (ASCT) after high-dose melphalan conditioning is considered a standard of care procedure for patients with multiple myeloma (MM). Current formulations of melphalan (eg, Alkeran for Injection [melphalan hydrochloride]; GlaxoSmithKline, Research Triangle Park, NC, USA) have marginal solubility and limited chemical stability upon reconstitution. Alkeran requires the use of propylene glycol as a co-solvent, which itself has been reported to cause such co...
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Background This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan–prednisone–lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma. Methods We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after...
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#1Omar S. Aljitawi (KU: University of Kansas)H-Index: 12
#2S. Ganguly (KU: University of Kansas)H-Index: 20
Last. Joseph McGuirk (KU: University of Kansas)H-Index: 19
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Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation
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#1Dionissios Neofytos (Johns Hopkins University)H-Index: 20
#2Lindsey R. Lombardi (Johns Hopkins University)H-Index: 4
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A 59-year-old man is diagnosed with multiple myeloma. It is recommended that he receive induction therapy followed by high-dose melphalan with autologous hematopoietic stem-cell transplantation. Such transplantation improves the remission rate in myeloma by allowing for the administration of a chemotherapy dose that would otherwise be lethal. This approach is considered appropriate only for relatively young patients without major coexisting illnesses.
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Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic an...
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