Spanish Registry of Erythropoietic Stimulating Agents Study

Completed

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT01739452
• Lead Sponsor: Grupo Español de Síndromes Mielodisplásicos

Brief Summary

Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.

Detailed Description

Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.

Study Timeline

• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Study Start: 2013-01
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

• The patient has given consent to the collection of data in the RESMD.
• Age ≥ 18 years.
• Patient must be diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL).
• The patient has studies at the time of diagnosis discard the possibility that MDS anemia is due to deficiency of factors (iron, vitamin B12 or folic acid).
• Initiation of treatment with ESAs or support transfusional at any spanish hematology service before December 31, 2011.

Exclusion Criteria

• Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect and evaluate the Spanish experience of anemia treatment.	6 months	Collect and evaluate retrospectively the Spanish experience of anemia treatment in patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1) evaluating the efficacy and safety of treatment with ESAs received for at least 24 weeks and the evolution of a control group of patients who received only transfusional support.

Secondary Outcome Measures

Name	Time	Method
Overall survival.	6 months	Evaluate overall survival in the two groups of patients, support transfusional versus ESA.
Duration of response	6 months	In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment.
Adverse events	6 months	Security: To determine the frequency, type, intensity and severity of adverse events and their possible relationship with the various ESA and progression to acute myelogenous leukemia.