A phase II study evaluating the efficacy and safety of Lenalidomide (Revlimid®) with or without Epoetin beta (NeoRecormon®) in transfusion-dependent ESA-resistant patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality - GFM-Len-Epo-08

Phase 1

• Conditions: patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality; MedDRA version: 12.0Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2008-008262-12-FR
• Lead Sponsor: Groupe Francophone des Myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified