Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, transfusion dependent, anaemia, cytogenetic abnormality 5q-, erythroid response, leukaemia, CC-5013, Celgene, revlimid, lenalidomide
Eligibility Criteria
Inclusion Criteria: Must understand and voluntarily sign an informed consent form Age 18 years at the time of signing the informed consent form Documented diagnosis of myelodysplastic syndromes (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low to intermediate-1-risk disease and has an associated del 5q(31) cytogenetic abnormality Red blood cell (RBC) transfusion dependent anaemia defined as not having any 56 days without a RBC transfusion within at least the immediate 112 days Must be able to adhere to the study visit schedule and other protocol requirements Women of childbearing potential must have a negative pregnancy test prior to inclusion Exclusion Criteria: Pregnant or lactating females Prior therapy with lenalidomide Proliferative (white blood cell (WBC)= 12,000/mL) chronic myelomonocytic leukemia (CMML) Prior >= grade-2 (using the National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) (v 3.0)) allergic reaction to thalidomide Prior desquamating (blistering) rash while taking thalidomide Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for >3 years Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days Less than 6 months since prior allogeneic bone marrow transplantation Less than 3 months since prior autologous bone marrow or stem cell transplantation Less than 28 days since prior myelosuppressive anticancer biologic therapy Recombinant human erythropoietin (rHuEPO) therapy received within 28 days Known human immunodeficiency virus (HIV-1) positivity Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
Sites / Locations
- AZ St-Jan Brugge AV
- UZ Gent
- UZ Gasthuisberg
- CHU Mont Godine
- Institut Paoli-Calmettes
- CHU d'Angers Service des Maladies du Sang
- Hopital Avicenne
- CHRU Lille Service des Maladies du Sang
- CHU Nantes Hematologie et Medicine interne
- CHU Archet 1Hematologie Clinique
- Hôpital Cochin Hematologie Clinique
- Centre Jean Bernhard Service Onco-Hematologie
- Centre Henri Becquerel Service d'Hematologie Clinique
- CHU Purpan, Place du Dr Baylac, Pavillon des Médecines
- CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines
- CHU Nancy Hematologie et Medecine interne
- Universitaetsklinikum Carl Gustav Carus
- St Johannes Hospital
- Universitaetsklinikum Freiburg
- Hannover Medical School
- Tel Aviv Sourasky Medical Center
- Ospedale Niguarda Ca Granda
- University of Pavia Division of Hematology
- University of Medical Centre
- Hematologie Erasmus MC
- Hospital Universitario de Salamanca
- Hospital Universitario La Fe
- SU/Sahlgrenska Section of Hematology & Coagulation
- Department of Medicine University Hospital
- Korolinska Institutet Department of Hematology
- University Hospital of Wales, Dept of Haematology
- Leed General Infirmary
- The Royal Bournemouth Hospital
- Ninewells Hospital and Medical School
- Kings College Hospital, Denmark Hill
- Central Manchester and Manchester Children's University Hospitals NHS Trust
- Nottingham City Hospital
- John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
Placebo
Lenalidomide 5 mg
Lenalidomide 10 mg
Placebo matching to active study arms.
Lenalidomide 5 mg daily 28/28 days
Lenalidomide 10 mg daily 21/28 days