Actively Recruiting
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
Led by The Affiliated People's Hospital of Ningbo University · Updated on 2026-02-17
92
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
T
The Affiliated People's Hospital of Ningbo University
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation
- Preconditioning regimen consists of melphalan at a dose of 200 mg/m8
- ECOG performance status score of 0 to 2
- Age greater than 18 years and less than 65 years
- Expected survival time greater than 3 months
- No intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting
- Ability to understand and provide written informed consent
You will not qualify if you...
- 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 less than 60 mL/min
- Inability to receive treatment and follow-up at the designated study site, or inability to understand, comply with study procedures, or provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
P
Peipei Ye
CONTACT
Y
Ying Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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