Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07413809

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

Led by The Affiliated People's Hospital of Ningbo University · Updated on 2026-02-17

92

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

T

The Affiliated People's Hospital of Ningbo University

Lead Sponsor

Z

Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation
  • Preconditioning regimen consists of melphalan at a dose of 200 mg/m8
  • ECOG performance status score of 0 to 2
  • Age greater than 18 years and less than 65 years
  • Expected survival time greater than 3 months
  • No intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting
  • Ability to understand and provide written informed consent
Not Eligible

You will not qualify if you...

  • 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 less than 60 mL/min
  • Inability to receive treatment and follow-up at the designated study site, or inability to understand, comply with study procedures, or provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

P

Peipei Ye

CONTACT

Y

Ying Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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