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Active, not recruiting Observational

A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain

NCT07465029 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-02-02
Last updated
2026-10-01

Condition(s) studied

Lower-risk Myelodysplastic Syndromes (TD LR-MDS)

Investigational drug(s) / intervention(s)

Erythropoiesis-stimulating agents (ESAs)Luspatercept →Lenalidomide →Hypomethylating agents (HMAs)Reb blood cell transfusion

Erythropoiesis-stimulating agents (ESAs): According to the product label

Luspatercept: According to the product label

Lenalidomide: According to the product label

Hypomethylating agents (HMAs): According to the product label

Reb blood cell transfusion: According to the product label

Study summary

The purpose of this study is to understand the incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) and describing real-world first-line treatment patterns, healthcare resource utilization, and associated clinical outcomes in adult patients with TD LR-MDS in Spain

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years at the time of lower-risk myelodysplastic syndromes (LR-MDS) diagnosis. * Documented diagnosis of LR-MDS identified through International Classification of Diseases (ICD) 9 codes recorded in medical history. In addition, recorded diagnosis of MDS with an explicitly documented International Prognostic Scoring System (IPSS) category of low or intermediate-1 and/or revised IPSS category of very low or low at or around the index date. * Evidence of transfusion dependence, defined as receiving ≥2 red blood cell (RBC) units within an 8-week interval, occurring within the selection window (January 1, 2021, to May 31, 2025, or the latest date ensuring detectable follow-up). * Active participants in BIG-PAC®, defined as ≥1 claim of any kind within 12 months prior to or on the index date (baseline period). * A minimum of 6 months of follow-up data available after the index date, unless the patient dies earlier Exclusion Criteria: * Diagnosis of high-risk MDS (HR-MDS) or another hematologic malignancy (e.g., acute myeloid leukemia) before the index date. * Documented transformation to acute myeloid leukemia (AML) or HR-MDS occurring before initiation of first-line treatment. * Participation in interventional clinical trials during the period of first-line treatment. * Presence of anemia secondary to non-MDS-related causes, such as nutritional deficiencies, advanced chronic kidney disease, or active bleeding, when such conditions preclude accurate attribution of transfusion dependence to MDS. * Lack of sufficient clinical history, defined as \<12 months of observable data before the index date. * Have missing key variables, e.g., age or sex. * Incomplete or inconsistent clinical information that prevents reliable evaluation of key study variables, including transfusion dependence status, treatment patterns, or outcomes.

Primary outcome measure(s)

  • Incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) — Up to 5-years
  • Prevalence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) — Up to 5-years

Trial sites (1)

FacilityCityRegionStatus
Local Institution - 0001 Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465029 on ClinicalTrials.gov ↗ ← All trials in Spain