Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality

PHASE2CompletedINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

June 1, 2003

Primary Completion Date

August 1, 2008

Study Completion Date

August 1, 2008

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

lenalidomide

10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen.

Trial Locations (32)

10029

Mt. Sinai Medical Center, New York

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester- James P. Wilmot Cancer Center, Rochester

15224

Western Pennsylvania Cancer Institute, Pittsburgh

30060

Northwest Georgia Oncology - Wellstar Cancer Research, Marietta

32224

Mayo Clinic, Jacksonville

33136

University of Miami Sylvester Comp Cancer Center, Miami

34461

Cancer & Blood Disease Center, Lecanto

44195

The Cleveland Clinic Foundation, Cleveland

55905

Mayo Clinic, Rochester

60077

Midwest Cancer Research Group, Skokie

60612

Rush-Presbyterian- St. Luke's Medical Center, Chicago

77030

MD Anderson Cancer Center, Houston

85258

Arizona Cancer Center, Scottsdale

85259

Mayo Clinic, Scottsdale

92270

Desert Hematology & Oncology Medical Group, Rancho Mirage

97201

Oregon Health & Science University, Portland

97227

Kaiser Permanente Northwest Region, Portland

98104

Swedish Cancer Institute, Seattle

85724-5024

Arizona Cancer Center, Tucson

94305-5750

Stanford University Medical Center, Stanford

33612-9497

H. Lee Moffitt Cancer Center and Research Institute, Tampa

60637-1470

University of Chicago Medical Center, Chicago

21287-8963

Johns Hopkins Oncology Center, Baltimore

02115-6084

Dana-Farber Cancer Institute, Boston

48201-2097

Wayne State University School of Medicine, Detroit

68198-7680

University of Nebraska Medical Center, Omaha

10021-0034

New York Hospital-Cornell, New York

10021-6007

Memorial Sloan-Kettering Cancer Center, New York

27157-1082

Wake Forest University School of Medicine, Winston-Salem

98109-4417

Fred Hutchinson Cancer Research Center, Seattle

Unknown

St. Johannes Hospital, Duisburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY