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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Michael Schuster, M.D.
Principal Investigator
Cornell Medical Center, Division of Hematology-Oncology
United States: Food and Drug Administration
PALO-05-05
NCT00306735
March 2006
December 2007
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Indiana Blood and Marrow Transplantation | Indianapolis, Indiana 46202 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Oregon Health & Science University | Portland, Oregon 97201 |
Cornell Medical Center | New York, New York 10021 |
Texas Transplant Institute | San Antonio, Texas 78229 |
Wake Forest Medical Center | Winston-Salem, North Carolina 27157 |
Fox Chase-Temple | Philadelphia, Pennsylvania 19111 |
Baylor University Blood and Marrow Transplantation | Dallas, Texas 75246 |
Fairfax-Northern Virginia Hematology-Oncology PC | Fairfax, Virginia 22031 |