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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
This study is ongoing, but not recruiting participants.
Study NCT00314743   Information provided by Washington University School of Medicine
First Received: April 12, 2006   Last Updated: April 15, 2009   History of Changes

April 12, 2006
April 15, 2009
March 2006
October 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00314743 on ClinicalTrials.gov Archive Site
 
 
 
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
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

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.

 
 
Interventional
Prevention, Randomized, Open Label, Parallel Assignment
  • Nausea
  • Vomiting
  • Drug: Carmustine, Etoposide, Cytarabine, Melphalan
  • Drug: Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan
Other: Control
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
 
October 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00314743
John DiPersio, MD, PhD, Washington University School of Medicine
03-1192
Washington University School of Medicine
 
Principal Investigator: John F DiPersio, M.D., Ph.D. Washington University School of Medicine
Washington University School of Medicine
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP