A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Lower Risk Myelodysplastic Syndrome (MDS) Without Del 5q
Completed · Phase 3 · Has a placebo group
Conditions studied: Anemia
In brief
The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.
Key facts
- Study ID
- NCT01029262
- Run by
- Celgene
- People needed
- 239
- Starts
- 2010-01-26
- Expected to finish
- 2018-05-09
- Last updated by the study team
- 2019-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31]
- Anemia that requires red blood cell transfusions
- Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
- Must agree to follow pregnancy precautions as required by the protocol.
- Must agree to receive counseling related to teratogenic and other risks of lenalidomide
- Must agree not to donate blood or semen
- Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study
You may not qualify if…
- Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents
- Allergic reaction to thalidomide
- Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method)
- Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed)
- Absolute neutrophil count (ANC) < 500/uL
- Platelets < 50,000/uL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal
- Uncontrolled hyperthyroidism or hypothyroidism
- Significant neuropathy
- Prior stem cell transplantation
- Anemia due to reasons other than MDS
- History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years
- Significant active cardiac disease within the past 6 months
- Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or active Hepatitis B infection
Where it is running
- Southern Illinois Hematology Oncology — Centralia, Illinois, United States
- Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Wollongong Hospital — Wollongong, New South Wales, Australia
- Royal Adelaide Hospital Institute of Medical and Veterinary Science — Adelaide, South Australia, Australia
- Princess Alexandra Hospital — Woolloongabba, Australia
- Medizinische Universitat Innsbruck — Innsbruck, Austria
- Krankenhaus der Elisabethinen Linz, I Interne Abteilung — Linz, Austria
- Universitatsklinik fur Innere Medizin Salzburg — Salzburg, Austria
- Wiener Gebietskrankenkasse-Hanusch-Krankenhaus — Vienna, Austria
- Klinikum Wels-Grieskirchen GmbH — Weis, Austria
- AZ St-Jan Brugge Oostende AV — Bruges, Belgium
- Cliniques Universitaires Saint-Luc — Brussels, Belgium
- Grand Hopital de Charleroi — Charleroi, Belgium
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium
- Centre Hospitalier Universitaire de Liege — Liège, Belgium
- Center Hospitalier Universitaire Ambroise Pare — Mons, Belgium
- Cliniques Universitaires UCL de Mont-Godine — Namur, Belgium
- Tom Baker Cancer Center — Calgary, Alberta, Canada
- University of Alberta Hospital — Edmonton, Alberta, Canada
- Cancer Care Manitoba — Winnepeg, Manitoba, Canada
- University of California at Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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