A Prospective, Randomized Phase III Trial of Oral Ondansetron and Dexamethasone Versus Oral Ondansetron, Dexamethasone and Apreptant (MK-869)for the Prevention of N/V Associated With Highly Emetogenic Preparative Regimens Prior to Stem Cell Transplantation.
This will be a single center, comparative, randomized, double-blind, phase III trial
designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in
combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea
and vomiting compared to ondansetron and dexamethasone in patients receiving highly
emetogenic preparative regimens prior to autologous or allogeneic (related and unrelated)
stem cell transplantation.
Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and
ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one
additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each
day of the preparative regimen plus one additional day combined with aprepitant, 125 mg
orally on the first day of their preparative regimen followed by 80 mg daily on each
remaining day of the preparative regimen plus three additional days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To compare rate of complete response and toxicity during and 3 days after high dose therapy in pts treated with NK-1 antagonist, aprepitant, plus ondansetron and dexamethasone compared to ondansetron and dexam
Patrick Stiff, MD
Loyola University Cardinal Bernadin Cancer Center
United States: Food and Drug Administration