Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.

This study has been completed.
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00306735
First received: March 22, 2006
Last updated: November 7, 2008
Last verified: November 2008
  Purpose

The primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients.


Condition Intervention Phase
Multiple Myeloma
Drug: Palonosetron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Phase 2 Study to Assess the Safety and Efficacy of Aloxi (Palonosetron HCl) for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving High-Dose Melphalan as Conditioning Chemotherapy for Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Estimated Enrollment: 75
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

A number of multiple-day chemotherapy regimens involving moderately or highly emetogenic agents are used for the treatment of cancers. Further, patients undergoing high-dose conditioning regimens in combination with bone marrow or stem cell transplants remain poorly controlled in terms of CINV. Patients treated with these regimens are at risk for developing CINV with each treatment as well as in the delayed setting.

Palonosetron to date, has been studied against single-day moderately and highly emetogenic chemotherapy regimens. It is of interest, therefore, to explore the safety and efficacy of palonosetron when administered during a multiple-day chemotherapy regimen. For this purpose, a population receiving melphalan (100 mg/m^2) as a conditioning regimen before stem cell transplant for the treatment of multiple myeloma was selected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. Age greater than or equal to 18 years
  3. Histologically confirmed multiple myeloma
  4. Karnofsky index greater than or equal to 50%
  5. Scheduled to receive a regimen containing melphalan at a dose of 100 mg/m^2 on Study Days -2 and -1 followed by autologous stem cell transplant on Day 0
  6. Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
  7. Women of childbearing potential must use reliable contraceptive measures and have negative pregnancy tests at screening

Exclusion Criteria:

  1. Inability or unwillingness to understand or to cooperate with the study procedures
  2. Received any investigational drugs within 30 days before study entry
  3. Received any drug with potential antiemetic efficacy within 24 hours prior to the start of chemotherapy on Study Day -2 or are scheduled to receive or anticipate use of any drug of this type (with the exception of palonosetron or dexamethasone as indicated for this study) during the trial, including the following:

    1. 5-HT3 receptor antagonists;
    2. Dopamine receptor antagonists (metoclopramide);
    3. Phenothiazine antiemetics (prochlorperazine, thiethylperazine and perphenazine);
    4. Atypical antipsychotic agents with Compazine-like activity (e.g. olanzapine, risperidone);
    5. Haloperidol, droperidol, tetrahydrocannabinol, or nabilone;
    6. Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), unless used as a preventative measure for chemotherapy toxicities. Topical or inhaled preparations are allowed; and,
    7. Any non-prescription medication, nutritional supplements, vitamins or herbal-type products known to either cause nausea or vomiting or used to treat nausea or vomiting.

    Note: with the exception of first-generation 5-HT3-receptor antagonists, above medication(s) may be used as rescue medication.

  4. Any vomiting, retching or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0, Grade 2-4 nausea in the 24 hours preceding chemotherapy;
  5. Ongoing vomiting for any organic etiology;
  6. Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in the protocol;
  7. Known contraindication to 5-HT3 receptor antagonists;
  8. Received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306735

Locations
United States, Indiana
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, United States, 46107
United States, New York
Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
Wake Forest Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase-Temple
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor University Blood and Marrow Transplantation
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Transplant Institute
San Antonio, Texas, United States, 78229
United States, Virginia
Fairfax-Northern Virginia Hematology-Oncology PC
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Eisai Inc.
Helsinn Healthcare SA
Investigators
Principal Investigator: Michael Schuster, M.D. Cornell Medical Center, Division of Hematology-Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306735     History of Changes
Other Study ID Numbers: PALO-05-05
Study First Received: March 22, 2006
Last Updated: November 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Multiple Myeloma
Stem Cell Transplantation
CINV

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014