Multiple Myeloma Clinical Trial
Official title:
A Double-blind Phase 2 Study to Assess the Safety and Efficacy of Aloxi (Palonosetron HCl) for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving High-dose Melphalan as Conditioning Chemotherapy for Stem Cell Transplantation
The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.
A number of multiple-day chemotherapy regimens involving moderately or highly emetogenic
agents are used for the treatment of cancers. Further, patients undergoing high-dose
conditioning regimens in combination with bone marrow or stem cell transplants remain poorly
controlled in terms of CINV. Patients treated with these regimens are at risk for developing
CINV with each treatment as well as in the delayed setting.
Palonosetron to date, has been studied against single-day moderately and highly emetogenic
chemotherapy regimens. It is of interest, therefore, to explore the safety and efficacy of
palonosetron when administered during a multiple-day chemotherapy regimen. For this purpose,
a population receiving melphalan (100 mg/m^2) as a conditioning regimen before stem cell
transplant for the treatment of multiple myeloma was selected.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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