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

December 1, 2016 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana Blood and Marrow Transplantation
    • New York
      • New York, New York, United States, 10021
        • Cornell Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase-Temple
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Blood and Marrow Transplantation
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Fairfax-Northern Virginia Hematology-Oncology PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Palonosetron
Drug: Palonosetron

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Collaborators

Helsinn Healthcare SA

Investigators

  • Principal Investigator: Michael Schuster, M.D., Cornell Medical Center, Division of Hematology-Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (Estimate)

March 24, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALO-05-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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