Treatment of anemia in myelodysplastic syndromes low risk with epoetin beta with Analysis of impact on quality of life and functional capacity - GFM-EPO-Qo

• Conditions: patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes; MedDRA version: 12.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2009-011161-87-FR
• Lead Sponsor: Groupe Francophone des Myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent;
•Must be 18 years of age or older at the time of screening ;
•Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not);
•For women of childbearing potential, need for effective contraception throughout the study period.

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

•Intensive Chemotherapy within 3 months before inclusion;
•Myelodysplastic Syndrome with IPSS score >1 ;
•Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
•EGOG > 3
•Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
•Uncontrolled arterial hypertension
•Life expectancy less than 6 months
•CMML
•Pregnant or breast feeding female subjects
•Patients with creatinine clearance less than 30ml/min

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: <br>Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;<br><br>;Primary end point(s): The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment<br>;Secondary Objective: •To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;<br>•Assess time to response<br>•Assess tolerance<br>•Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;<br>•Assess functional capacity: <br> Cardiovascular performance on effort by the 6-minute walk test <br> Performing the « Short Physical Performance Battery » tests<br>