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
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