NCT06588413RecruitingPhase 3
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
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
Source: ClinicalTrials.gov · Last updated 22 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 17 Sept 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Augusta University
- Diseases
- Multiple myeloma
- NCT number
- NCT06588413
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 172
- From 17 Sept 2024 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Allergy to olanzapine
Other
- Chronic alcoholism
- Pregnant
- Decline or unable to provide informed consent
Who the study is looking for
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wellstar MCG Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.