Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen

February 12, 2026 updated by: The Affiliated People's Hospital of Ningbo University

A Prospective, Multicenter, Randomized Controlled Trial of Fosaprepitant Combined With Tropisetron and Multi-Day Olanzapine Versus Fosaprepitant Combined With Tropisetron and Dexamethasone for the Prevention of Delayed Nausea and Vomiting Induced by High-Dose Chemotherapy in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

This study employs a prospective, multicenter, randomized, two-arm design aimed at evaluating the efficacy and safety of the FTO regimen in preventing delayed chemotherapy-induced nausea and vomiting (CINV) following high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT). A total of 92 patients with multiple myeloma who were indicated for autologous HSCT were enrolled. The primary endpoint was to compare the complete response (CR) rates of the FTO regimen versus the FTD regimen in the delayed phase (24-240 hours after chemotherapy) for preventing nausea and vomiting induced by high-dose chemotherapy during HSCT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on strict inclusion and exclusion criteria, 92 patients with multiple myeloma from 11 hospitals were enrolled. Eligible subjects were randomly assigned in a 1:1 ratio to either the experimental group (FTO regimen) or the control group (FTD regimen).The FTO regimen was administered as follows:Fosaprepitant 150 mg (intravenously every 72 hours starting from the initiation of preconditioning chemotherapy until day +6 after HSCT),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Olanzapine 5 mg (orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurred first).The FTD regimen was administered as follows: Fosaprepitant 150 mg (intravenously 30 minutes before chemotherapy on day -3),Tropisetron 5 mg (intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2),Dexamethasone 6 mg (orally 30 minutes before chemotherapy on day -3),and 3.75 mg (orally on days -2 to 0).

The study compared the complete response (CR) rates of the FTO regimen versus the FTD regimen during the acute phase (preconditioning chemotherapy period and 0-24 hours after chemotherapy) and the overall phase (preconditioning chemotherapy period and 0-240 hours after chemotherapy). It also observed and compared the major response (MR), clinical benefit response (CBR), minor response (MiR), and treatment failure (TF) between the two regimens during the acute, delayed, and overall phases. Additionally, the toxic side effects of the FTO and FTD regimens were observed and compared.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • The Affiliated People's Hospital of Ningbo University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation;
  • Preconditioning regimen consists of melphalan at a dose of 200 mg/m²;
  • ECOG performance status score of 0 to 2;
  • Age >18 years and <65 years;
  • Expected survival time >3 months;
  • Absence of intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting;
  • Ability to understand and provide written informed consent.

Exclusion Criteria:

  • Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications;
  • Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs;
  • History of hypersensitivity to fosaprepitant or olanzapine;
  • Serum creatinine clearance <60 mL/min;
  • Inability to receive treatment and follow-up at the designated study site, or inability to comprehend, comply with the study protocol, or provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FTO regimen
Fosaprepitant, Tropisetron and Olanzapine.
Drug: Fosaprepitant
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
Drug: Fosaprepitant
150mg, intravenously 30 minutes before chemotherapy on day -3
Drug: Tropisetron
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
Drug: Olanzapine
5mg, orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurs first
Active Comparator: FTD regimen
Fosaprepitant, Tropisetron and Dexamethasone.
Drug: Fosaprepitant
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
Drug: Fosaprepitant
150mg, intravenously 30 minutes before chemotherapy on day -3
Drug: Tropisetron
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
Drug: Dexamethasone
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response (CR)
Time Frame: 24 to 240 hours after chemotherapy
No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.
24 to 240 hours after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Response (MR)
Time Frame: 0-240 hours after chemotherapy
No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use.
0-240 hours after chemotherapy
Clinical Benefit Response (CBR)
Time Frame: 0-240 hours after chemotherapy
CR+MR.
0-240 hours after chemotherapy
Minor Response (MiR)
Time Frame: 0-240 hours after chemotherapy
No more than 1-2 vomiting episodes per day, but vomiting occurring on no more than 3 days during the assessment period, with or without nausea of any severity, with permissible use of rescue medication.
0-240 hours after chemotherapy
Treatment Failure (TF)
Time Frame: 0-240 hours after chemotherapy
More than 2 vomiting episodes on any day during the assessment period, or more than 1 vomiting episode per day on 3 or more days during the assessment period.
0-240 hours after chemotherapy
Toxic Side Effects
Time Frame: 0-240 hours after chemotherapy
Toxicity and adverse reaction assessment based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
0-240 hours after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated People's Hospital of Ningbo University

Collaborators

Jinhua People's Hospital
Zhejiang University
The Central Hospital of Lishui City
First Affiliated Hospital of Wenzhou Medical University
Shaoxing People's Hospital
Shaoxing Second Hospital
Jinhua Central Hospital
Taizhou Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Zhejiang Provincial Tongde Hospital
Dongyang People's Hospital

Investigators

  • Principal Investigator: Peipei Ye, The Affiliated People's Hospital of Ningbo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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