RecruitingPhase 3NCT07413809

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


Sponsor

The Affiliated People's Hospital of Ningbo University

Enrollment

92 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two anti-nausea medication regimens for patients with multiple myeloma who are receiving high-dose chemotherapy (melphalan) before a stem cell transplant, to see which better controls delayed nausea and vomiting that can occur several days after chemotherapy. **You may be eligible if...** - You have multiple myeloma and are scheduled for an autologous stem cell transplant (using your own stem cells) - Your preparatory chemotherapy regimen includes high-dose melphalan (200 mg/m²) - You are between 18 and 65 years old - Your overall health is adequate (ECOG 0-2) and expected survival is more than 3 months - You do not have increased pressure in the skull or gastrointestinal obstruction **You may NOT be eligible if...** - You have nausea or vomiting within 48 hours before enrollment, with prior antiemetic use - You are currently taking certain medications that interact with the study drugs (CYP3A4 inducers or inhibitors) - You have a known allergy to fosaprepitant or olanzapine - Your kidney function is significantly reduced (creatinine clearance below 60 mL/min) - You are unable to complete treatment and follow-up at the study site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFosaprepitant

150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT

DRUGFosaprepitant

150mg, intravenously 30 minutes before chemotherapy on day -3

DRUGTropisetron

5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2

DRUGOlanzapine

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

DRUGDexamethasone

6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0


Locations(1)

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

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NCT07413809


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