Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplasia
Eligibility Criteria
Inclusion Criteria:
MDS defined as
- Low or int-1 IPSS score
- Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)
- De novo MDS, excluding therapy-related MDS AND
- Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8 weeks )
- Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks
- Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy during the next 12 months
- ECOG performance status ≤ 2
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Adequate liver function (transaminases serum levels ≤ 3N)
- Adequate renal function (calculate creatinine clearance > 50 ml/min)
- Female subjects of chilbearing potential* must :
Agree to use effective contraception without interruption throughout the study and for at least 4 weeks after the end of treatment
• Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and during one week after end of treatment if their partner is of childbearing potential.
Exclusion Criteria:
- Active serious infection not controlled by oral or intravenous antibiotics
- Platelets less than 50 G/L
- Prior history of deep vein thrombosis or pulmonary embolism
- Previous treatment by Thalidomide
- Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy were given
- Rapidely progressive disease with copromised organ function judged to be life-threatening by the Investigator
- Pregnant or lactating female
- Known human immunodeficiency virus (HIV) infection
- Known active hepatitis B and/or C virus infection
- Hypersensitivity or intolerance to Lenalidomide or any of the excipients
- Hypersensitivity to Epoetin beta or any of the excipients
- Uncontrolled arterial hypertension
- Any history of malignancy (other than myelodysplastic syndrome) unless the patient has remained disease free for more than 5 years
Sites / Locations
- Hematology Dpt, Service d'Hématologie Clinique
- Hematology Dpt, CHU de Bicêtre
- Hematology Dpt, CHU Cochin
- Chu Amiens
- CHU Angers
- Hematology Dpt, CH d'Avignon-305 rue Follereau-
- CH de la Cote Basque
- centre de Blois
- Hopital Avicenne
- Hematology Dpt, CHU Haut-Lévèque
- Hôpital Boulogne Sur Mer
- hôpital Morvan
- CHU Clémenceau
- CH de Carcassonne
- Hematology Dpt, CH René Dubos
- CHU de Clermont-Ferrand
- CH de Compiègne
- Hematology Dpt, Hôpital Sud Francilien
- hopital Henri Mondor
- CHU de Dijon
- Hematology Dpt, Hôpital Versailles
- Hematology Dpt,CH Le mans
- CHRU Huriez
- Hopital Saint-Vincent de Paul
- CHRU de Limoges
- Hematology Dpt, Centre Hospitalier Lyon Sud
- CH de Mantes-la-jolie
- Institut Paoli Calmettes
- Hematology Dpt, CHU Brabois
- Hematology Dpt, CHU de nantes
- Hematology Dpt, CHU Archet
- Hematology Dpt, CHU Caremeau
- Hematology Dpt, CHR La Source orléans
- centre René Huguenin
- Hematology Dpt, Hôpital la pitié-Salpétrière
- Hematology Dpt, Hopital Saint Louis
- Hopital Saint Antoine
- Hematology Dpt, Hôpital Maréchal Joffre
- Hôpital Jean Bernard
- Hematology Dpt, Centre Hospitalier de la région d'Annecy
- CHRU de Reims
- CHU Pontchaillou
- Centre Henri Becquerel
- CH de Saint Quentin
- Chu Strasbourg
- Hematology Dpt, CHU PURPAN
- Hematology Dpt, CH CHU Bretoneau
- centre hopitalier princesse Grace
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A
Arm B
Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses. Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician. The patients will be followed every 3 months for 12 months
Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w). Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician. The patients will be followed every 3 months for 12 months