Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamet… (NCT07413809) | Clinical Trial Compass
RecruitingPhase 3
Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen
China92 participantsStarted 2025-10-31
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Response (CR)
Timeframe: 24 to 240 hours after chemotherapy
Trial details
NCT IDNCT07413809
SponsorThe Affiliated People's Hospital of Ningbo University