Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588413
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Olanzapine 25 Vs 5 Mg in Quadruplet NauseaVomiting Prophylaxis Before High-Dose Melphalan
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-Blind Study of FOND Fosaprepitant ONdansetron Dexamethasone Plus Either Olanzapine 25 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:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FONDO-LOW
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 previous research study found the 10 mg dose of olanzapine combined with 3 standard medications used routinely to prevent nauseavomiting to be effective for patients who received melphalan chemotherapy but several other studies have shown many patients have a side effect of sleepiness eg sedation with that dose of the medication Our study will compare two lower doses of olanzapine 5 mg and 25 mg in combination with the 3 standard medications used to prevent nauseavomiting 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None