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| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2008 | ||||
| Last Updated Date | June 16, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00631930 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Palonosetron, Aprepitant, and Low-Dose Dexamethasone in Preventing Nausea and Vomiting in Patients Undergoing High-Dose Chemotherapy and Stem Cell Transplant for Multiple Myeloma or Lymphoma | ||||
| Official Title ICMJE | 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 | RATIONALE: Giving palonosetron together with aprepitant and low-dose dexamethasone may prevent nausea and vomiting in patients undergoing high-dose chemotherapy and stem cell transplant for multiple myeloma or lymphoma. PURPOSE: This phase II trial is studying how well giving palonosetron, aprepitant, and low-dose dexamethasone works in preventing nausea and vomiting in patients undergoing high-dose chemotherapy and stem cell transplant for multiple myeloma or lymphoma. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients are stratified according to diagnosis (multiple myeloma vs lymphoma).
Patients may receive prochlorperazine or promethazine hydrochloride, lorazepam*, metoclopramide hydrochloride, scopolamine, diphenhydramine hydrochloride or dronabinol as rescue medications for breakthrough emesis. NOTE: *The single dose lorazepam given prior to HSCT is not considered rescue medication. Patients in both groups complete a daily diary documenting and rating episodes of nausea and vomiting beginning 24 hours after initiation of the first dose of chemotherapy until day 7 post-transplantation. Patients also complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and modified Osoba module questionnaires for quality of life assessment beginning 24 hours after initiation of the first dose of chemotherapy and on days -6 to -1 and on days 3 and 7. PROJECTED ACCRUAL: A total of 20 patients (10 multiple myeloma patients and 10 lymphoma patients) will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* 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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00631930 | ||||
| Responsible Party | Delva Deauna-Limayo, Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | ||||
| Study ID Numbers ICMJE | CDR0000583228, KUMC-10862, MGI-KUMC-10862 | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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