Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and
 delayed chemotherapy induced nausea and vomiting when administered in combination with
 intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous
 transplant setting.
Inclusion Criteria:

 -  Male or female patients 18 years of age or older

 -  Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell
 transplant therapy per usual transplant inclusion and exclusion criteria

 -  Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or
 Amyloidosis

 -  Written informed consent

 Exclusion Criteria:

 -  Nausea at baseline

 -  Chronic use of other antiemetic agent(s)

 -  Gastrointestinal obstruction or active peptic ulcer

 -  Radiation therapy to pelvis or abdomen within 1 week before or after study day 1

 -  Allogeneic stem cell transplant recipient

 -  Aspartate transaminase (AST) > 3x upper limit of normal (ULN)

 -  Alanine transaminase (ALT) > 3x ULN

 -  Bilirubin > 3x ULN

 -  Alkaline phosphatase > 3x ULN

 -  Creatinine > 2

 -  Documented hypersensitivity to any component of study regimen

 -  Pregnant or lactating women

 -  Participating in a clinical trial which involves other investigational agent(s)

 -  Patients taking any of the following medications at time of study day 1: warfarin,
 oral contraceptives (except for the administration of stopping menses), tolbutamide,
 phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.