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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
This study is currently recruiting participants.
Study NCT00631930   Information provided by National Cancer Institute (NCI)
First Received: March 7, 2008   Last Updated: June 16, 2009   History of Changes

March 7, 2008
June 16, 2009
October 2007
February 2010   (final data collection date for primary outcome measure)
  • Frequency and percent of patients who have complete control, complete emetic response, major emetic response, and minor emetic occurrence [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00631930 on ClinicalTrials.gov Archive Site
 
 
 
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
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

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.

OBJECTIVES:

Primary

  • To assess emetic responses to multi-day doses of palonosetron hydrochloride and aprepitant in combination with low-dose dexamethasone with or without prochlorperazine in patients with multiple myeloma or lymphoma undergoing high-dose chemotherapy and autologous hematopoietic stem cell transplantation, utilizing the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).

Secondary

  • To assess the impact of nausea and vomiting on the quality of life of these patients using the "modified" Osoba module.
  • To evaluate non-hematologic toxicities in patients treated with this regimen.

OUTLINE: Patients are stratified according to diagnosis (multiple myeloma vs lymphoma).

  • Group 1 (multiple myeloma): Patients receive high-dose chemotherapy for multiple myeloma (comprising melphalan IV on days -3 to -2). They also receive dexamethasone IV over 5-10 minutes and oral aprepitant on days -3 to -1 and palonosetron hydrochloride IV over 30 seconds on days -3 and -2 and on day 3. Patients undergo HSCT on day 0.
  • Group 2 (lymphoma): Patients receive high-dose chemotherapy for lymphoma (comprising carmustine IV once on day -7, cytarabine IV twice daily and etoposide IV twice daily on days -6 to -3, and cyclophosphamide once daily on days -6 to -3). They also receive dexamethasone IV over 5-10 minutes on days -7 to -3, oral aprepitant on days -7 to -5, and palonosetron hydrochloride IV over 30 seconds on days -7 to -3 and on day 3. Patients undergo HSCT on day 0.

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.

Phase II
Interventional
Supportive Care, Open Label
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Nausea and Vomiting
  • Drug: aprepitant
  • Drug: carmustine
  • Drug: cyclophosphamide
  • Drug: cytarabine
  • Drug: dexamethasone
  • Drug: etoposide
  • Drug: melphalan
  • Drug: palonosetron hydrochloride
  • Procedure: autologous hematopoietic stem cell transplantation
  • Experimental: Patients receive high-dose chemotherapy for multiple myeloma (comprising melphalan IV on days -3 to -2). They also receive dexamethasone IV over 5-10 minutes and oral aprepitant on days -3 to -1 and palonosetron hydrochloride IV over 30 seconds on days -3 and -2 and on day 3. Patients undergo HSCT on day 0.
  • Experimental: Patients receive high-dose chemotherapy for lymphoma (comprising carmustine IV once on day -7, cytarabine IV twice daily and etoposide IV twice daily on days -6 to -3, and cyclophosphamide once daily on days -6 to -3). They also receive dexamethasone IV over 5-10 minutes on days -7 to -3, oral aprepitant on days -7 to -5, and palonosetron hydrochloride IV over 30 seconds on days -7 to -3 and on day 3. Patients undergo HSCT on day 0.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
 
February 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma or lymphoma
  • Candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation as deemed by the treating institution
  • Must have at least 2.5 x 10^6 cryopreserved CD34+ cells/kg available for transplantation
  • No primary or secondary brain neoplasms with increased intracranial pressure
  • No nausea or vomiting episodes

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • 18-75 years of age (multiple myeloma patients)
  • 18-65 years of age (lymphoma patients)
  • Karnofsky performance status 60-100%
  • ANC ≥ 1,000/mm³
  • Platelets ≥ 75,000/mm³
  • Serum bilirubin < 2.5 mg/dL
  • Liver function test ≤ 1.5 times upper limit of normal
  • Calculated creatinine clearance of 50% (lymphoma patients only)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Multiple myeloma patients undergoing hemodialysis are eligible
  • LVEF ≥ 48% by MUGA scan
  • Room air pulse oximetry ≥ 93%
  • FEV_1 and DLCO ≥ 50% of predicted values
  • Must be able to complete the antiemesis assessment questionnaire

Exclusion criteria:

  • Active infection requiring intravenous antibiotics
  • Known active hepatitis B and/or hepatitis C infections
  • HIV infection
  • Prior malignancies at other sites except surgically treated nonmelanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for ≥ 5 years
  • Uncontrolled medical problems including any of the following:

    • Diabetes mellitus
    • Cardiac disease (i.e., congestive heart failure, coronary artery disease, or arrhythmias)
    • Pulmonary disease
    • Hepatic disease
    • Renal disease, unless renal insufficiency is felt to be secondary to multiple myeloma
  • Myocardial infarction within the past 6 months
  • Morbid obesity (BMI > 40)
  • Psychiatric or CNS disorders interfering with ability to comply with study protocol
  • Known hypersensitivity to 5-HT3 antagonists and aprepitant and their components

PRIOR CONCURRENT THERAPY:

  • At least 24 hours since prior intrathecal chemotherapy
  • More than 4 weeks since prior major surgery
  • Not receiving any antiemetic medication within 24 hours of receiving study medications
  • No concurrent therapeutic anticoagulant therapy for venous thromboembolic episode or other hypercoagulable states

    • Coumadin 1 mg for central venous catheter prophylaxis allowed
  • More than 72 hours since prior and no concurrent use of non-prescription or herbal-type medications

    • Concurrent multivitamins without iron, nutritional supplements (i.e., Boost), and other electrolyte replacements allowed
Both
18 Years to 75 Years
No
 
United States
 
NCT00631930
Delva Deauna-Limayo, Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
CDR0000583228, KUMC-10862, MGI-KUMC-10862
University of Kansas
 
Study Chair: Delva Deauna-Limayo, MD University of Kansas
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP