Non Hodgkin Lymphoma Clinical Trial
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
Summary
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.
Eligibility Criteria
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.
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There is 1 Location for this study
St. Louis Missouri, 63110, United States
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