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Completed

NCT Number: NCT02939287

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

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

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Key information

Conditions

Nausea Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

This is a multi-center, randomized, non-inferiority phase 3 study conducted to determine an appropriate anti-emetic regimen for patients receiving melphalan for an autologous stem cell transplant (SCT). Candidates for this trial will include patients aged 18-80 years with hematologic malignancies receiving high dose melphalan as part of a conditioning regimen for an autologous stem cell transplant. Patients will be enrolled in 3 arms. Patients in Arm A will receive an aprepitant containing anti-emetic regimen. Patients in Arm B will receive an olanzapine containing anti-emetic regimen. Patients in Arm C will receive an aprepitant plus olanzapine containing anti-emetic regimen. Patients must be able to tolerate oral medications.

Patients will be carefully monitored for rates of emesis, nausea, and mucositis. Any adverse events will be recorded. Impact on quality of life will also be assessed. A total of 184 patients will be accrued to each arm. It is anticipated that the accrual period will last approximately 2-3 years. The primary endpoint of this study is a complete response, defined as no emesis and no rescue therapy within 120 hours of melphalan administration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Autologous transplant containing high dose melphalan as part of the conditioning regimen (single or 2 day melphalan; BEAM [carmustine, etoposide, cytarabine, melphalan])
  • able to tolerate oral medications

Exclusion criteria

  • Nausea/vomiting within 12 hours before planned high dose conditioning chemotherapy
  • Any anti-emetic treatment within 24 hours before planned high dose conditioning chemotherapy
  • Pregnancy
  • Baseline corrected QT interval (QTc) > 500 ms
  • History of seizures
  • History of central nervous system (CNS) disease
  • Human immunodeficiency virus (HIV)

Treatment and study plan

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

Drug

Add aprepitant to anti-emetic regimen

Other names: Emend

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

Drug

add olanzapine to anti-emetic regimen

Other names: Zyprexa

Aprepitant plus Olanzapine

Drug

add aprepitant and olanzapine to anti-emetic regimen

Other names: Emend, Zyprexa

Primary outcomes

  1. Complete Response (CR)

    Time frame: within 120 hours following melphalan administration; no emesis and no rescue therapy within 120 hours of melphalan administration (within 120 hours following last day of melphalan administration at baseline)

    no emesis and no rescue anti-emetic therapy

Secondary outcomes

  1. Acute Complete Response

    Time frame: 0 (transplant time) to 24 hours post-transplant

    no emesis or rescue therapy; Acute complete response defined as no emesis or rescue therapy required from time point of 0 to 24 hours following melphalan therapy administration

  2. Delayed Complete Response

    Time frame: 25-120 hours post-transplant

    no emesis or rescue therapy administered; Delayed complete response defined as no emesis or rescue therapy required from time point of 25 hours to 120 hours following melphalan therapy administration

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 20, 2016
Registry last updated
Oct 22, 2024

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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