Spanish Registry of Erythropoietic Stimulating Agents Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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National Registry of Patients Diagnosed With Low-risk Myelodysplastic Syndromes According to the Criteria of the WHO / French-American-British Classification System (FAB) and IPSS and Treated With Erythropoietic Agents.

Conditions
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Myelodysplastic Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| erythropoiesis-stimulating agents<br>Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents. | |
| Transfusion support<br>A control group of patients who received only transfusional support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and evaluate the Spanish experience of anemia treatment. | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response | In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment. | 6 months | 
| Overall survival. | Evaluate overall survival in the two groups of patients, support transfusional versus ESA. | 6 months | 
| Adverse events | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-risk MDS, myelodysplastic syndrome, retrospective