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Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
Sponsor: The Affiliated People's Hospital of Ningbo University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2025-10-31
Completion Date
2027-09
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Fosaprepitant
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
Fosaprepitant
150mg, intravenously 30 minutes before chemotherapy on day -3
Tropisetron
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
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
Dexamethasone
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
Locations (1)
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China