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Trial Title:
Olanzapine 2.5 Vs 5 Mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
NCT ID:
NCT06588413
Condition:
Multiple Myeloma
Autologous Stem Cell Transplantation
Conditions: Official terms:
Multiple Myeloma
Nausea
Vomiting
Olanzapine
Conditions: Keywords:
CINV
Nausea
Olanzapine
Melphalan
autologous transplant
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Olanzapine
Description:
Subjects will be randomized to either olanzapine 2.5 mg or 5 mg
Arm group label:
Olanzapine 2.5 mg
Arm group label:
Olanzapine 5 mg
Other name:
Zyprexa
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.
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 high-dose melphalan conditioning chemotherapy before autologous
stem cell transplantation to determine chemotherapy-induced nausea and vomiting (CINV)
and sedation outcomes.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wellstar MCG
Address:
City:
Augusta
Zip:
30912
Country:
United States
Contact:
Last name:
Amber Clemmons, PharmD
Phone:
706-721-6493
Email:
aclemmons@augusta.edu
Start date:
October 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Augusta University
Agency class:
Other
Source:
Augusta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06588413
