patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes MedDRA version: 12.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: Neorecormon® 30 000 UI
Pharmaceutical Form: Solution for injection
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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; ;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 ;Secondary Objective: •To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response; •Assess time to response •Assess tolerance •Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales; •Assess functional capacity: Cardiovascular performance on effort by the 6-minute walk test Performing the « Short Physical Performance Battery » tests | — |
Countries
France
Outcome results
None listed