NCT06588413 Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
| NCT ID | NCT06588413 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Augusta University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 172 participants in total. It began in 2024-09-17 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06588413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06588413 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 172 participants.
Is NCT06588413 currently recruiting?
Yes, NCT06588413 is actively recruiting participants. Contact the research team at aclemmons@augusta.edu for enrollment information.
Where is the NCT06588413 trial being conducted?
This trial is being conducted at Augusta, United States.
Who is sponsoring the NCT06588413 clinical trial?
NCT06588413 is sponsored by Augusta University. The trial plans to enroll 172 participants.