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Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Vomiting

Intervention: Carmustine, Etoposide, Cytarabine, Melphalan (Drug); Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
John F DiPersio, M.D., Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
Nicholas Fisher, Phone: 314-454-5102, Email: nfisher@dom.wustl.edu

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.

Clinical Details

Official title: A Pilot Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation

Study design: Prevention, Randomized, Open Label, Parallel Assignment

Primary outcome: To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 or Multiple Myeloma

- 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

- Known hypersensitivity to any component of study regimen

- Pregnant or lactating women

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

Locations and Contacts

Nicholas Fisher, Phone: 314-454-5102, Email: nfisher@dom.wustl.edu

Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Nicholas Fisher, Phone: 314-454-5102, Email: nfisher@dom.wustl.edu
Additional Information

Starting date: March 2006
Last updated: October 27, 2008

Page last updated: February 12, 2009

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