Aprepitant for the control of delayed nausea and vomiting associated with the use of high-dose melphalan for autologous peripheral blood stem cell transplants in patients with multiple myeloma: a phase II study.
OBJECTIVE
The aim of this study is to evaluate the efficacy of aprepitant as part of the antiemetic regimen for high-dose melphalan conditioning in multiple myeloma patients.


METHODS
This is a prospective, single-arm study.


METHODS
The study was conducted at an Academic Medical Facility.


METHODS
Twenty-six patients receiving high-dose melphalan with autologous stem cell support were included in this study.


METHODS
Eligible patients were >18 years with a diagnosis of MM undergoing high-dose melphalan followed by autologous peripheral blood stem cell transplantation (PBSCT). All patients had serum aminotransferases and total bilirubin less than 2× upper limit of normal. Treatment consisted of aprepitant 125 mg orally on day 1, followed by 80 mg orally 24 and 48 h after the initial dose; ondansetron 16 mg orally day 1; dexamethasone 12 mg orally day 1, and 8 mg orally days 2-4 with breakthrough medications as needed.


RESULTS
Patients were evaluated for the frequency of emetic episodes, the need for breakthrough antiemetic medication, and the mean nausea score in 24-h increments beginning 24 h after chemotherapy and continuing until 120 h. Nausea score was determined using a linear analog scale (0-10). Complete response (CR) was defined as no more than one (1) emetic episode during the evaluation period. A total of 26 patients (17 male, 9 female) were enrolled in the study. Of these, 25 (96 %) were complete responders and 24 (92 %) had no documented emetic episodes during the study period. One patient (4 %) had 1 emetic episode and one patient (4 %) had 2 emetic episodes. Some degree of nausea was reported by 23/26 patients, and the mean nausea score for the entire group over the study period was 0.7 (range 0-10).


CONCLUSIONS
Addition of aprepitant to standard antiemetics resulted in low rates of delayed nausea/vomiting associated with high-dose melphalan and PBSCT, and has now become standard practice in this patient population at our institution.
Stem Cell Transplant, Arthur G. James Cancer Hospital, The Ohio State University, Columbus, OH, USA.
Thomas
T
Bechtel
Ali
A
McBride
Brooke
B
Crawford
Susan
S
Bullington
Craig C
CC
Hofmeister
Don M
DM
Benson
Samantha
S
Jaglowski
Sam
S
Penza
Leslie A
LA
Andritsos
Steven M
SM
Devine
D000932:Antiemetics / Q000627:therapeutic use*; D000077608:Aprepitant; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009101:Multiple Myeloma / Q000188:drug therapy / Q000628:therapy*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D019172:Transplantation Conditioning / Q000009:adverse effects* / Q000379:methods; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant; D008558:Melphalan