Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.
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
1 other identifier
interventional
75
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Mar 2006
Shorter than P25 for phase_2 multiple-myeloma
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 22, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedDecember 5, 2016
November 1, 2015
1.8 years
March 22, 2006
December 1, 2016
Conditions
Keywords
Study Arms (1)
Palonosetron
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent
- Age greater than or equal to 18 years
- Histologically confirmed multiple myeloma
- Karnofsky index greater than or equal to 50%
- 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
- Known mild to moderate hepatic, renal or cardiovascular impairment may be enrolled at the discretion of the investigator
- Women of childbearing potential must use reliable contraceptive measures and have negative pregnancy tests at screening
You may not qualify if:
- Inability or unwillingness to understand or to cooperate with the study procedures
- Received any investigational drugs within 30 days before study entry
- 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:
- HT3 receptor antagonists;
- Dopamine receptor antagonists (metoclopramide);
- Phenothiazine antiemetics (prochlorperazine, thiethylperazine and perphenazine);
- Atypical antipsychotic agents with Compazine-like activity (e.g. olanzapine, risperidone);
- Haloperidol, droperidol, tetrahydrocannabinol, or nabilone;
- Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone), unless used as a preventative measure for chemotherapy toxicities. Topical or inhaled preparations are allowed; and,
- 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.
- 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;
- Ongoing vomiting for any organic etiology;
- Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in the protocol;
- Known contraindication to 5-HT3 receptor antagonists;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Helsinn Healthcare SAcollaborator
Study Sites (10)
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, 46107, United States
Cornell Medical Center
New York, New York, 10021, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase-Temple
Philadelphia, Pennsylvania, 19111, United States
Baylor University Blood and Marrow Transplantation
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Fairfax-Northern Virginia Hematology-Oncology PC
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Schuster, M.D.
Cornell Medical Center, Division of Hematology-Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2006
First Posted
March 24, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
December 5, 2016
Record last verified: 2015-11