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| Sponsor: | University of Kansas |
|---|---|
| Collaborator: |
Eisai Inc. |
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
| Enrollment: | 20 |
| Study Start Date: | October 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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:
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Omar Aljitawi, MD | University of Kansas |
More Information
| Responsible Party: | Omar Aljitawi, M.D., University of Kansas Medical Center |
| ClinicalTrials.gov Identifier: | NCT00600353 History of Changes |
| Obsolete Identifiers: | NCT00631930 |
| Other Study ID Numbers: | 10862 |
| Study First Received: | January 7, 2008 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Dexamethasone acetate Dexamethasone Aprepitant Dexamethasone 21-phosphate BB 1101 Palonosetron Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |