Comparing two doses of olanzapine for preventing nausea in multiple myeloma patients receiving chemotherapy
Official title: Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study
Run by Augusta University · NCT06588413 · Data updated 2026-11-12
This study is testing whether two lower doses of olanzapine can help prevent nausea and vomiting in multiple myeloma patients receiving chemotherapy before a stem cell transplant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 172 (estimated) |
| Sponsor | Augusta University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Augusta, Georgia) |
| Status | Recruiting |
| Started | September 17, 2024 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 22, 2024 |
| Trial ID | NCT06588413 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with multiple myeloma who are scheduled to receive high-dose melphalan as part of their autologous stem cell transplantation.
✕Probably not a fit
Patients with allergies to olanzapine or those who have experienced nausea or vomiting within 24 hours prior to enrollment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of two lower doses of olanzapine (2.5 mg and 5 mg) in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with multiple myeloma undergoing high-dose melphalan treatment before autologous stem cell transplantation. The study employs a randomized, double-blinded design, where participants will receive either dose of olanzapine in combination with three standard antiemetic medications. The goal is to determine which dose effectively reduces nausea and vomiting while minimizing sedation side effects.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less sedating option for preventing nausea and vomiting in patients undergoing chemotherapy.
How similar studies have gone: Previous studies have shown that higher doses of olanzapine can effectively reduce nausea and vomiting, but this approach of using lower doses is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receipt of high-dose melphalan 140-200 mg/m2 * Autologous stem cell transplantation recipient Exclusion Criteria: * Allergy to olanzapine * Documented nausea or vomiting within 24 hours prior to enrollment * Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days prior to enrollment or planned during protocol therapy * Chronic alcoholism * Pregnant * Decline or unable to provide informed consent
Where it's running
-
Wellstar MCG
Augusta, Georgia, United States Recruiting
Study contacts
- Study coordinator: Amber Clemmons, PharmD, BCOP, FHOPA
- Email: aclemmons@augusta.edu
- Phone: 706-721-6493
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.