Preventing delayed nausea and vomiting after autologous transplant with olanzapine versus dexamethasone 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

This trial tests whether adding nightly olanzapine to a fosaprepitant+tropisetron regimen prevents delayed chemo-related nausea and vomiting better than a regimen using dexamethasone in adults with multiple myeloma undergoing high-dose melphalan and autologous stem cell transplant.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Affiliated People's Hospital of Ningbo University (Government)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Ningbo, Zhejiang)
• Trial ID: NCT07413809 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter, randomized Phase 3 trial enrolled 92 patients with multiple myeloma scheduled for autologous hematopoietic stem cell transplantation after high-dose melphalan. Participants were randomized 1:1 to an experimental FTO regimen (fosaprepitant given every 72 hours, tropisetron, and nightly olanzapine) or a control FTD regimen (fosaprepitant, tropisetron, and dexamethasone). The primary endpoint was complete response (no emesis and no rescue medication) in the delayed phase (24–240 hours after chemotherapy), with acute and overall phases and additional response categories also compared. Safety and adverse events were monitored through day +8 post-transplant.

Who should consider this trial

Good fit: Adults 18–65 years with multiple myeloma planned for autologous HSCT using melphalan 200 mg/m², ECOG 0–2, expected survival >3 months, and adequate renal function (CrCl ≥60 mL/min) are the intended candidates.

Not a fit: Patients with recent vomiting or antiemetic use, significant renal impairment (CrCl <60 mL/min), hypersensitivity to fosaprepitant or olanzapine, current CYP3A4-interacting medications, or inability to attend the designated study site are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the olanzapine-containing regimen could reduce delayed nausea and vomiting after high-dose chemotherapy, improving patient comfort and reducing the need for rescue antiemetics.

How similar studies have performed: Previous randomized trials in other chemotherapy settings have shown olanzapine-containing antiemetic regimens can improve control of delayed CINV compared with standard dexamethasone-containing regimens, so this approach is supported by prior evidence.

Eligibility criteria

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.

Where this trial is running

Ningbo, Zhejiang

• The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Peipei Ye — The Affiliated People's Hospital of Ningbo University
• Study coordinator: Peipei Ye

Conditions Multiple Myeloma; Delayed vomiting; Fosaprepitant; Olanzapine; Tropisetron