A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence
Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.
Up to 2 years
No
Alan F List, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
CC-5013-MDS-003
NCT00065156
June 2003
August 2008
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Stanford University Medical Center | Stanford, California 94305-5408 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Swedish Cancer Institute | Seattle, Washington 98104 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Mayo Clinic | Jacksonville, Florida 32224 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
Oregon Health & Science University | Portland, Oregon 97201 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Midwest Cancer Research Group | Skokie, Illinois 60077 |
Mayo Clinic | Scottsdale, Arizona |
The Cleveland Clinic Foundation | Cleveland, Ohio |
Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
Cancer & Blood Disease Center | Lecanto, Florida 34461 |
Northwest Georgia Oncology - Wellstar Cancer Research | Marietta, Georgia 30060 |
Wayne State University School of Medicine | Detroit, Michigan 48201-2097 |
Mt. Sinai Medical Center | New York, New York 10029 |
Kaiser Permanente Northwest Region | Portland, Oregon 97227 |
Desert Hematology & Oncology Medical Group | Rancho Mirage, California 92270 |
University of Miami Sylvester Comp Cancer Center | Miami, Florida 33136 |
Rush-Presbyterian- St. Luke's Medical Center | Chicago, Illinois 60612 |
New York Hospital-Cornell | New York, New York 10021-0034 |
University of Rochester- James P. Wilmot Cancer Center | Rochester, New York 14642 |