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Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan

NCT02939287 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-10-22

Study results available
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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

Conditions

Interventions

DRUG

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

Add aprepitant to anti-emetic regimen

DRUG

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

add olanzapine to anti-emetic regimen

DRUG

Aprepitant plus Olanzapine

add aprepitant and olanzapine to anti-emetic regimen

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Kathryn Schultz, PharmD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-23
Primary Completion
2021-12-30
Completion
2022-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02939287 on ClinicalTrials.gov