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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306735
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : December 5, 2016
Helsinn Healthcare SA
Information provided by:
Eisai Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: Palonosetron Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Palonosetron Drug: Palonosetron

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306735

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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
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Fox Chase-Temple
Philadelphia, Pennsylvania, United States, 19111
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
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Principal Investigator: Michael Schuster, M.D. Cornell Medical Center, Division of Hematology-Oncology
Layout table for additonal information Identifier: NCT00306735    
Other Study ID Numbers: PALO-05-05
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2015
Keywords provided by Eisai Inc.:
Multiple Myeloma
Stem Cell Transplantation
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms, Digestive
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action