TY - JOUR
T1 - Arsenic Trioxide with Ascorbic Acid and High-Dose Melphalan
T2 - Results of a Phase II Randomized Trial
AU - Qazilbash, Muzaffar H.
AU - Saliba, Rima M.
AU - Nieto, Yago
AU - Parikh, Gaurav
AU - Pelosini, Matteo
AU - Khan, Fatima B.
AU - Jones, Roy B.
AU - Hosing, Chitra
AU - Mendoza, Floralyn
AU - Weber, Donna M.
AU - Wang, Michael
AU - Popat, Uday
AU - Alousi, Amin
AU - Anderlini, Paolo
AU - Champlin, Richard E.
AU - Giralt, Sergio
PY - 2008/12
Y1 - 2008/12
N2 - Arsenic trioxide (ATO) is synergistic with ascorbic acid (AA) and melphalan against myeloma both in vitro and in vivo. The aim of this randomized phase II trial was to determine the safety and efficacy of a combination of ATO, melphalan, and AA as preparative regimen in 48 patients undergoing autologous hematopoietic stem cell transplantation (ASCT) for multiple myeloma (MM). Forty-eight patients received melphalan 200 mg/m2 i.v. over 2 days and AA 1000 mg i.v. over 7 days in 3 treatment arms: no ATO (arm 1), ATO 0.15 mg/kg i.v. × 7 days (arm 2), and ATO 0.25 mg/kg i.v. × 7 days (arm 3). No dose-limiting toxicity, engraftment failure, or nonrelapse mortality (NRM) was seen in the first 100 days post-ASCT. Complete responses (CR) were seen in 12 of 48 patients (25%), with an overall response rate (ORR = CR + PR) of 85%. Median progression-free survival (PFS) was 25 months; median overall survival (OS) has not yet been reached. There was no significant difference in CR, PFS, or OS among the 3 treatment arms, and no adverse effect of ATO on melphalan pharmacokinetics. Addition of ATO + AA to high-dose melphalan is safe and well tolerated as a preparative regimen for MM.
AB - Arsenic trioxide (ATO) is synergistic with ascorbic acid (AA) and melphalan against myeloma both in vitro and in vivo. The aim of this randomized phase II trial was to determine the safety and efficacy of a combination of ATO, melphalan, and AA as preparative regimen in 48 patients undergoing autologous hematopoietic stem cell transplantation (ASCT) for multiple myeloma (MM). Forty-eight patients received melphalan 200 mg/m2 i.v. over 2 days and AA 1000 mg i.v. over 7 days in 3 treatment arms: no ATO (arm 1), ATO 0.15 mg/kg i.v. × 7 days (arm 2), and ATO 0.25 mg/kg i.v. × 7 days (arm 3). No dose-limiting toxicity, engraftment failure, or nonrelapse mortality (NRM) was seen in the first 100 days post-ASCT. Complete responses (CR) were seen in 12 of 48 patients (25%), with an overall response rate (ORR = CR + PR) of 85%. Median progression-free survival (PFS) was 25 months; median overall survival (OS) has not yet been reached. There was no significant difference in CR, PFS, or OS among the 3 treatment arms, and no adverse effect of ATO on melphalan pharmacokinetics. Addition of ATO + AA to high-dose melphalan is safe and well tolerated as a preparative regimen for MM.
KW - Arsenic trioxide
KW - AutologousIntroduction
KW - Myeloma
UR - http://www.scopus.com/inward/record.url?scp=56549083786&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=56549083786&partnerID=8YFLogxK
U2 - 10.1016/j.bbmt.2008.09.019
DO - 10.1016/j.bbmt.2008.09.019
M3 - Article
C2 - 19041063
AN - SCOPUS:56549083786
SN - 1083-8791
VL - 14
SP - 1401
EP - 1407
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
IS - 12
ER -