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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Palonosetron
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem Cell Transplantation, CINV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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: 5-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; Received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.

Sites / Locations

  • Indiana Blood and Marrow Transplantation
  • Cornell Medical Center
  • Wake Forest Medical Center
  • Oregon Health & Science University
  • University of Pennsylvania
  • Fox Chase-Temple
  • Baylor University Blood and Marrow Transplantation
  • MD Anderson Cancer Center
  • Texas Transplant Institute
  • Fairfax-Northern Virginia Hematology-Oncology PC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palonosetron

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 22, 2006
Last Updated
December 1, 2016
Sponsor
Eisai Inc.
Collaborators
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT00306735
Brief Title
Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.
Collaborators
Helsinn Healthcare SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Stem Cell Transplantation, CINV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palonosetron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Palonosetron

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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: 5-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; Received, or will receive, radiotherapy of upper abdomen or cranium or total body irradiation within one week prior to or during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schuster, M.D.
Organizational Affiliation
Cornell Medical Center, Division of Hematology-Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Blood and Marrow Transplantation
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Wake Forest Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase-Temple
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Baylor University Blood and Marrow Transplantation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fairfax-Northern Virginia Hematology-Oncology PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

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

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