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;
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;
Parallel
Fosaprepitant
Drug150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT
Fosaprepitant
Drug150mg, intravenously 30 minutes before chemotherapy on day -3
Tropisetron
Drug5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2
Olanzapine
Drug5mg, 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
Drug6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0
Complete Response (CR)
No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.
Major Response (MR)
No vomiting with severe nausea (scoring 8-10 on the MASCC Antiemesis Tool), and no rescue medication use.
Clinical Benefit Response (CBR)
CR+MR.
Minor Response (MiR)
No more than 1-2 vomiting episodes per day, but vomiting occurring on no more than 3 days during the assessment period, with or without nausea of any severity, with permissible use of rescue medication.
Treatment Failure (TF)
More than 2 vomiting episodes on any day during the assessment period, or more than 1 vomiting episode per day on 3 or more days during the assessment period.
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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
