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.
• 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.