Clinical trial NCT00314743: Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nausea
Vomiting
Keywords: Patients with Non-Hodgkins Lymphoma or Multiple Myeloma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2006-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Primary outcomes:
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.
timeFrame: Day 30
Secondary outcomes:
measure: 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.
timeFrame: Day 30
measure: To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group
timeFrame: Day 30
measure: 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.
timeFrame: Day 30
measure: To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.
timeFrame: Day 30
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: John F DiPersio, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: