NCT07413809RecruitingPhase 3
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
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
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 31 Oct 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Diseases
- Multiple myeloma
- NCT number
- NCT07413809
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 92
- From 31 Oct 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- History of hypersensitivity to fosaprepitant or olanzapine;
Lab values
- Serum creatinine clearance \<60 mL/min;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated People's Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.