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Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen

RecruitingPhase 3Ages 18 Years - 65 YearsAllThe Affiliated People's Hospital of Ningbo Univer…
NCT07413809 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Fosaprepitant
  • Fosaprepitant
  • Tropisetron
  • Olanzapine
  • Dexamethasone
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Where

1 site
The Affiliated People's Hospital of Ningbo University
Ningbo, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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