Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
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
The Affiliated People's Hospital of Ningbo University
92 participants
Oct 31, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria5
- 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.
Interventions
150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
150mg, intravenously 30 minutes before chemotherapy on day -3
5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
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
6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
Locations(1)
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NCT07413809