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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Affiliated People's Hospital of Ningbo University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Fosaprepitant
  • Fosaprepitant
  • Tropisetron
  • Olanzapine
  • Dexamethasone

Treatment groups

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Affiliated People's Hospital of Ningbo University

Lead sponsor

Zhejiang University

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

The Central Hospital of Lishui City

Collaborator

Jinhua Central Hospital

Collaborator

Shaoxing People's Hospital

Collaborator

Shaoxing Second Hospital

Collaborator

Jinhua People's Hospital

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Dongyang People's Hospital

Collaborator

Taizhou Hospital

Collaborator