Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT06588413
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olanzapine — DRUG
    Subjects will be randomized to either olanzapine 2.5 mg or 5 mg

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
Nov 2024
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Olanzapine 2.5 mg
    Olanzapine 2.5 mg dose to be given on the day of high-dose melphalan and three days after
  • Active Comparator: Olanzapine 5 mg
    Olanzapine 5 mg dose to be given on the day of high-dose melphalan and three days after

Primary Outcome Measure

Complete Response [ Time Frame: From day of chemotherapy (acute phase) through 5 days after chemotherapy (delayed phase) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellstar MCGAugustaGeorgia30912
Amber Clemmons, PharmD
[email protected]
706-721-6493

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