Active, not recruiting
Observational
A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain
Condition(s) studied
Lower-risk Myelodysplastic Syndromes (TD LR-MDS)
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Local Institution - 0001 |
Madrid |
Spain |
|
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