Status:
RECRUITING
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
Lead Sponsor:
Augusta University
Conditions:
Multiple Myeloma
Autologous Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
This study is a randomized, double-blinded trial comparing olanzapine 2.5 mg vs 5 mg in combination with standard triplet antiemetic prophylaxis in patients with multiple myeloma who are receiving hig...
Eligibility Criteria
Inclusion
- Receipt of high-dose melphalan 140-200 mg/m2
- Autologous stem cell transplantation recipient
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT06588413
Start Date
September 17 2024
End Date
October 1 2027
Last Update
November 22 2024
Active Locations (1)
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1
Wellstar MCG
Augusta, Georgia, United States, 30912