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
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Complete Response (CR) — 24 to 240 hours after chemotherapy No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.
Trial sites (1)
Facility
City
Region
Status
The Affiliated People's Hospital of Ningbo University
Ningbo
Zhejiang
Recruiting
More The Affiliated People's Hospital of Ningbo University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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