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Tracking Information | |||||
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First Received Date † | January 7, 2008 | ||||
Last Updated Date | September 15, 2008 | ||||
Start Date † | October 2007 | ||||
Current Primary Outcome Measures † |
To determine the efficacy and assess the antiemetic response of the combination of Aprepitant and Palonosetron with Prochlorperazine, Lorazepam and low doses of Dexamethasone in achieving complete control from vomiting and nausea among hematopoietic stem [ Time Frame: 24 hours, Day 3, Day 7 ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00600353 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Multi-Day Doses in Prevention of Nausea and Emesis | ||||
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 | ||||
Brief Summary | 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). |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | Experimental: Group A: Subjects with Multiple Myeloma
Group B: Subjects with Lymphoma
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 20 | ||||
Estimated Completion Date | January 2010 | ||||
Estimated Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed. |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00600353 | ||||
Responsible Party | Delva Deauna-Limayo, MD, University of Kansas Medical Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Kansas | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | University of Kansas | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |