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Completed

NCT Number: NCT00314743

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.

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Key information

Conditions

Nausea Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vascular Diseases Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

Other names: Zofran

Dexamethasone

Drug

Aprepitant

Drug

Other names: Emend

Primary outcomes

  1. 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: Day 30

Secondary outcomes

  1. To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant.

    Time frame: Day 30

  2. To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group

    Time frame: Day 30

  3. To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group.

    Time frame: Day 30

  4. To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

A 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Apr 14, 2006
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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