Multiple Myeloma Clinical Trials

Find Multiple Myeloma Clinical Trials Near You

Randomized, Double-Blind Study of FOND (Fosaprepitant, ONdansetron, Dexamethasone) Plus Either Olanzapine 2.5 mg Versus 5 mg for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients Receiving High-dose Melphalan Conditioning: The FONDO-LOW Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Receipt of high-dose melphalan 140-200 mg/m2

• Autologous stem cell transplantation recipient

Locations
United States
Georgia
Wellstar MCG
RECRUITING
Augusta
Contact Information
Primary
Amber Clemmons, PharmD, BCOP, FHOPA
aclemmons@augusta.edu
706-721-6493
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2027-10
Participants
Target number of participants: 172
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Augusta University

This content was sourced from clinicaltrials.gov