Multiple Myeloma Clinical Trial

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Prophylactic Use of Maribavir for the Prevention of Cytomegalovirus (CMV) Disease in Stem Cell Transplant Recipients

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Summary

The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

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Full Description

Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.

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Eligibility Criteria

Inclusion Criteria:

Allogeneic stem cell transplant recipient
Recipient or donor CMV seropositive
Have transplant engraftment
Able to swallow tablets

Exclusion Criteria:

CMV organ disease
HIV infection
Use of other anti-CMV therapy post-transplant

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

681

Study ID:

NCT00411645

Recruitment Status:

Completed

Sponsor:

Shire

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There are 94 Locations for this study

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University of Arkansas Myeloma Institute
Little Rock Arkansas, 72205, United States
City of Hope Medical Center
Duarte California, 91010, United States
Scripps Green Hospital
La Jolla California, 92037, United States
UCSD Moores Center
La Jolla California, 92093, United States
UCLA Medical Center
Los Angeles California, 90095, United States
University of California, San Francisco
San Francisco California, 94143, United States
Stanford University Medical Center
Stanford California, 94305, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Shands Hospital
Gainesville Florida, 32610, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Northwestern University Medical Center
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Loyola University
Maywood Illinois, 60153, United States
St Francis Hospital
Beech Grove Indiana, 46107, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
University Medical Center University of Louisville Hospital
Louisville Kentucky, 40202, United States
Greenbaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusettes General
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Wayne State Medical Center
Detroit Michigan, 48201, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic College of Medicine
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
New York Presbyterian Hospital,Weill Cornell Medical Center
New York New York, 10021, United States
Mount Sinai Hospital
New York New York, 10029, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of North Carolina Hospital
Chapel Hill North Carolina, 27599, United States
Duke Medical Center
Durham North Carolina, 27710, United States
Wake Forest Medical Center
Winston-Salem North Carolina, 27157, United States
The Jewish Hospital
Cincinnati Ohio, 45236, United States
Ireland Cancer Center Case Western Reserve University
Cleveland Ohio, 44106, United States
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Oregon Health and Sciences University
Portland Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Thomas Jefferson
Philadelphia Pennsylvania, 19107, United States
Jeanes Hospital - Temple
Philadelphia Pennsylvania, 19111, United States
Western Pennsylvania Cancer Institute
Pittsburgh Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15232, United States
Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Methodist Hospital
Houston Texas, 77030, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States
Latter Day Saints Hospital
Salt Lake City Utah, 84103, United States
Medical College of Virginia
Richmond Virginia, 23298, United States
VA Puget Sound Health Center
Seattle Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
West Virginia University Hospital
Morgantown West Virginia, 26506, United States
ZNA Stuivenberg
Antwerp , 2060, Belgium
AZ Sint Jan, Department of Hematology
Brugge , 8000, Belgium
Cliniques Universitaires St,Luc Dept Hematology
Brussels , 1200, Belgium
UZ Gasthuisberg
Leuven , 3000, Belgium
CHU Sart -Tilman Department of Medicine, Hematology
Liege , 4000, Belgium
QEII Health Sciences Center
Halifax Nova Scotia, B3H2Y, Canada
McMaster University Medical Center
Hamilton Ontario, L8N 3, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
Ottawa General Campus
Ottawa, Ontario, K1H 8, Canada
Hopital l'Enfant Jesus
Quebec , G1J 1, Canada
Hopital Henri Mondor
Créteil , 94010, France
Edouard Herriot Hopital
Lyon, Cedex 03 , 69437, France
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
Hopital Hotel Dieu
Nantes, Cedex 1 , 44093, France
Hopital St. Louis
Paris Cedex 10 , 75475, France
Hopital Haut-Leveque
Pessac , 33600, France
Univ. Clinic Dresden
Dresden , 01307, Germany
University Clinic of Dresden
Dresden , 01307, Germany
University of Essen
Essen , 45122, Germany
University of Freiburg
Freiburg , 79106, Germany
University of Hamburg-Eppendorf
Hamburg , 20246, Germany
Hannover, Medizinische Hochschule
Hannover , 30625, Germany
University of Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Koeln, Clinic I for internal Medicine
Koeln , 50937, Germany
Johannes-Gutenberg University
Mainz , 55131, Germany
University Clinic of Ulm
Ulm , 89081, Germany
Careggi University Hospital
Firenze , 50134, Italy
University of San Martino Hospital
Genova , 16132, Italy
San Raffaele del Monte Tabor
Milano , 20132, Italy
Pescara Hospital
Pescara , 65123, Italy
Bianchi-Melacrino-Morelli Hospital
Reggio Calabria , 89100, Italy
Barcelona Hospital
Barcelona , 08036, Spain
Duran i Reynals Hospital
Barcelona , 08907, Spain
University of Salamanca
Salamanca , E-370, Spain
Karolinska University Hospital
Huddinge Stockholm, 14186, Sweden
Sahlgrenska University Hospital
Goteborg , S-413, Sweden
Karolinska University Hospital,Huddinge
Stockholm , 141 8, Sweden
Akademiska Sjukhuset, Dept Hematology
Uppsala , 751 8, Sweden
University College Hospital
London , NW1 2, United Kingdom
Royal Free Hospital
London , NW3 2, United Kingdom
Hammersmith Hospital
London , W12 O, United Kingdom
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How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

681

Study ID:

NCT00411645

Recruitment Status:

Completed

Sponsor:


Shire

How clear is this clinincal trial information?

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