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Sponsors and Collaborators: |
Eisai Medical Research Inc. Helsinn Healthcare SA |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00306735 |
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Palonosetron |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 75 |
Study Start Date: | March 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on Study Day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:
Note: with the exception of first-generation 5-HT3-receptor antagonists, above medication(s) may be used as rescue medication.
United States, Indiana | |
Indiana Blood and Marrow Transplantation | |
Beech Grove, Indiana, United States, 46107 | |
United States, New York | |
Cornell Medical Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Wake Forest Medical Center | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Fox Chase-Temple | |
Philadelphia, Pennsylvania, United States, 19111 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Texas Transplant Institute | |
San Antonio, Texas, United States, 78229 | |
Baylor University Blood and Marrow Transplantation | |
Dallas, Texas, United States, 75246 | |
United States, Virginia | |
Fairfax-Northern Virginia Hematology-Oncology PC | |
Fairfax, Virginia, United States, 22031 |
Principal Investigator: | Michael Schuster, M.D. | Cornell Medical Center, Division of Hematology-Oncology |
Study ID Numbers: | PALO-05-05 |
Study First Received: | March 22, 2006 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00306735 |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma Stem Cell Transplantation CINV |
Melphalan Vomiting Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Serotonin Multiple Myeloma Palonosetron Hemorrhagic Disorders Multiple myeloma Nausea Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neurotransmitter Agents Serotonin Antagonists Neoplasms Serotonin Agents Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |