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Sponsors and Collaborators: |
University of Kansas MGI PHARMA, Inc. Merck |
Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00600353 |
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 |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Lymphoma Multiple Myeloma Nausea and Vomiting |
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
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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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |||||
University of Kansas Cancer Center and Medical Pavilion | |||||
Westwood, Kansas, United States, 66205 |
University of Kansas |
MGI PHARMA, Inc. |
Merck |
Principal Investigator: | Delva Deauna-Limayo, MD | University of Kansas |
Responsible Party: | University of Kansas Medical Center ( Delva Deauna-Limayo, MD ) |
Study ID Numbers: | 10862 |
First Received: | January 7, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00600353 |
Health Authority: | United States: Institutional Review Board |
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