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| Sponsors and Collaborators: |
University of Kansas Eisai Medical Research Inc. Merck |
|---|---|
| Information provided by: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00600353 |
Purpose
To assess emetic responses to multi-day doses of Palonosetron and Aprepitant and low dose dexamethasone +/- Prochlorperazine among patients with multiple myeloma and lymphoma undergoing autologous HSCT utilizing the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma, Plasma-Cell Lymphoma, Malignant |
Drug: Palonosetron Drug: Aprepitant Drug: Dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Combined Use of Multi-Day Doses of Palonosetron and Aprepitant With Low Doses Dexamethasone in Prevention of Nausea and Emesis Among Patients With Multiple Myeloma and Lymphoma Undergoing Autologous Stem Cell Transplant: A Pilot Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Group A: Subjects with Multiple Myeloma
Group B: Subjects with Lymphoma
|
Drug: Palonosetron
Palonosetron 0.25 mg IV over 30 seconds
Drug: Aprepitant
Aprepitant 125 mg PO and Aprepitant 80 mg PO
Drug: Dexamethasone
Dexamethasone 4 mg IV and Dexamethasone 4 mg IV push
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed.
Contacts and Locations| Contact: Marilyn Labinski, RN, BSN, OCN | (913) 588-4254 | mlabinski@kumc.edu |
| United States, Kansas | |
| Kansas University Cancer Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Marilyn Labinski, RN 913-588-4254 mlabinski@kumc.edu | |
| Principal Investigator: | Delva Deauna-Limayo, MD | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( Delva Deauna-Limayo, MD ) |
| Study ID Numbers: | 10862 |
| Study First Received: | January 7, 2008 |
| Last Updated: | June 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00600353 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Inflammatory Agents Dexamethasone Neurotransmitter Agents Vomiting Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Nausea Lymphoma Dexamethasone acetate |
Aprepitant Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Glucocorticoids Serotonin Multiple Myeloma Lymphatic Diseases Palonosetron Peripheral Nervous System Agents Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Dexamethasone Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Serotonin Antagonists Hemorrhagic Disorders Therapeutic Uses |
Cardiovascular Diseases Lymphoma Dexamethasone acetate Aprepitant Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Gastrointestinal Agents Vascular Diseases Glucocorticoids Pharmacologic Actions Multiple Myeloma Lymphatic Diseases |