Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
Recruiting
Phase 3
Interventional Study
Multiple Myeloma
Autologous Stem Cell Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 172 (estimated)
- Sponsor
- Augusta University · Other
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About This Trial
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 chemoth…
Trial Locations
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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, quet…
Contacts