CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1 +2 moredrug
Likely dose
o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02939287
NCT02939287Phase 3Completed
CompareCT.gov

Aprepitant- and Olanzapine- Containing Regimens for Prevention of Acute and Delayed Nausea and Vomiting Associated With High Dose Melphalan and BEAM in Autologous Stem Cell Transplant Patients

Rush University Medical Center·interventional·Posted Oct 20, 2016·Updated Oct 22, 2024

In Brief

A Phase 3 clinical trial evaluating o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1, Olanzapine10 mg orally daily on Days -1,0,+1 and +2, and 1 other intervention for Nausea and Vomiting. Completed, enrolled 52 participants across 1 site.

Detailed Summary

The purpose of this study is to help answer the following research question: * Whether administration of an aprepitant containing regimen, an olanzapine containing regimen or regimen containing both will prevent nausea and vomiting better for patients undergoing an autologous stem cell transplant with melphalan chemotherapy. Both of these medications are approved by the United States Food and Drug Administration (FDA) for nausea and vomiting. * Participants will be randomly assigned to one of the 3 treatment groups: * Arm A: aprepitant containing anti-emetic therapy * Arm B: olanzapine containing anti-emetic therapy * Arm C: Aprepitant plus olanzapine containing anti-emetic therapy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNausea, Vomiting
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 20, 2016
Enrollment StartSep 23, 2017
Primary CompletionDec 30, 2021
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.7 years ago

Interventions

o Aprepitant 125 mg orally one hour prior to chemotherapy on Day -1 and 80 mg orally on Days 0 and +1drug

Add aprepitant to anti-emetic regimen

Olanzapine10 mg orally daily on Days -1,0,+1 and +2drug

add olanzapine to anti-emetic regimen

Aprepitant plus Olanzapinedrug

add aprepitant and olanzapine to anti-emetic regimen