Multi-day Doses in Prevention of Nausea and Emesis

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00600353
First received: January 7, 2008
Last updated: February 18, 2011
Last verified: February 2011
  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 2

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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

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 ]

Secondary Outcome Measures:
  • To evaluate the frequency and intensity of nausea and vomiting using the Multination Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). [ Time Frame: 24 hours, Day 3, Day 7 ] [ Designated as safety issue: Yes ]
  • To assess the impact of nausea and vomiting on the quality of life of patients undergoing autologous HSCT using the Osoba module. [ Time Frame: 24 hours, Day 3, Day 7 ] [ Designated as safety issue: Yes ]

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

  • Conditioning regimen, over a 7 day period, includes:
  • Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion

Group B: Subjects with Lymphoma

  • Conditioning regimen, over a 7 day period, includes: (BEAC)
  • BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
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
Criteria

Inclusion Criteria:

  1. Patients with multiple myeloma and lymphoma deemed by the treating institution to be candidates for high dose chemotherapy and autologous hematopoietic stem cell transplant.
  2. Both males and females are eligible.
  3. Patients should be 18 years old; multiple myeloma patients up to age 75 and lymphoma patients up to age 65 are eligible.
  4. Patients with Karnofsky performance status of 60% or better.
  5. Patients should have at least 2.5 x 106 cyropreserved CD34+ cells per kilogram available for transplantation.
  6. Patients with adequate bone marrow function as defined as ANC ≥1000 cells/mm3 , platelet ≥ 75,000 cells/mm3.
  7. Lymphoma patient must have adequate renal function as defined by a calculated creatinine clearance of 50% measured in ml/min.
  8. The criteria for renal function does not apply for multiple myeloma patients. Multiple myeloma patients undergoing hemodialysis are eligible.
  9. All patients must have a MUGA scan indicating a left ventricular ejection fraction (LVEF) of greater or equal to 48% within 42 days prior to registration.
  10. Patients must have adequate pulmonary function as defined by room air pulse oximetry equal to or greater than 93%, and pulmonary function tests (FEV1 and DLCO) equal to or greater than 50% of predicted values.
  11. Patients with adequate hepatic function as defined by serum bilirubin lower than 2.5 mg/dL and liver function tests to not exceed greater than 1.5x of the institutions ULN.
  12. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with the institutional and federal guidelines.
  13. Patients must be able to complete the anti-emesis assessment questionnaire. A Spanish questionnaire will be available for Hispanic-speaking patients.

Exclusion Criteria:

  1. Patients with nausea and have emetic episodes, and are receiving any anti-emetic medication taken within 24 hours of receiving antibiotics.
  2. Active infection involving intravenous antibiotics.
  3. Patients with known active hepatitis B and/or hepatitis C infections are excluded.
  4. Patients with known HIV infection.
  5. Primary or secondary brain neoplasms with increased intracranial pressure.
  6. Received intrathecal chemotherapy within 24 hours of first dose of conditioning chemotherapy.
  7. Patients who are nursing mothers or pregnant. Females of childbearing age are required to have a negative serum B-HCG pregnancy test 24 hours prior to enrollment on the study.
  8. Patients with previous malignancies at other sites except surgically treated nonmelanomatous skin cancers, prostate cancer or superficial cervical cancers, or other cancer from which the patient had been disease free for 5 or more years.
  9. Patients with uncontrolled medical problems such as diabetes mellitus, cardiac (i.e. congestive heart failure, coronary heart disease, arrhythmias), pulmonary hepatic and renal disease unless renal insufficiency is felt to be secondary to multiple myeloma,
  10. Myocardial infarction within 6 months of enrollment in the study.
  11. Major surgery within 4 weeks of enrollment.
  12. Morbid obesity (BMI>40)
  13. Patients with psychiatric or central nervous systems disorders interfering with ability to comply with study protocol.
  14. Patients receiving therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoaguable states. Coumadin at 1 mg as prophylaxis for central venous catheter is allowed.
  15. Known hypersensitivity to 5-HT3 antagonists and Aprepitant and their components.
  16. Use of non-prescription and herbal-type medications within 72 hours of enrollment on the study. Their use are not allowed during the study. Multivitamins, nutritional supplements such as Boost, and other electrolyte replacements are allowed.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600353

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Eisai Inc.
Investigators
Principal Investigator: Omar Aljitawi, MD University of Kansas
  More Information

No publications provided

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
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
Fosaprepitant
Dexamethasone 21-phosphate
BB 1101
Palonosetron
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014