patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality MedDRA version: 12.0 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: Lenalidomide (Revlimid®)
Product Name: REVLIMID®
Pharmaceutical Form: Capsule*
Trade Name: NEORECORMON 30 000 U
Pharmaceutical Form: Solution for injection
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion 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 (ca lculate creatinine clearance > 50 ml/min) •Female subjects of chilbearing potential* must : -Understand the study drug is expected to have a teratogenic risk. -Understand that even if she has amenorrhea, she must follow all the advice on effective contraception. -She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy •Male patients taking lenalidomide must : -Agree the use of a condom if engaged in sexual activity with a woman of childbearing potential, during the entire period of treatment, even if dysruption of treatment and during one week after end of treatment. -Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. •All subjects must : -Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. -Agree not to share study medication with another person and to return all unused study drug to the investigator. •Signed informed consent prior to start of any study-specific procedures •Ability to participate to a clinical trial and adhere to study procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Erythroid response rate after 4 courses, assessed according to IWG 2006 criteria ;Secondary Objective: •Safety of Lenalidomide and of its combination with Epoetin beta: adverse events (type, frequency, severity) and relationship of adverse events to study drug •% of major HI-E and minor HI-E after 4 courses according to IWG 2000 criteria •Erythroid response duration •Time to response •Time to progression according to IPSS •RBC transfusion independence •Prognostic factors of response •Survival •Quality of life ;Primary end point(s): The primary endpoint of the trial will be to compare the efficacy of Lenalidomide to Lenalidomide with Epoetin beta in ESA-resistant MDS by evaluating the erythroid response rate according to the IWG 2006 response criteria at 4 months of therapy | — |
Countries
France
Outcome results
None listed