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NCT07465029Active, not recruiting

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

Observational Retrospective Study on Incidence, First-line Treatment Patterns, and Clinical Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain Using the BIG-PAC® Database

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1300 (estimated)
First submitted
24 Feb 2026
Start date
2 Feb 2026
Primary completion date
23 Apr 2026
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT07465029

What you commit to

  • Study type: Observational
  • Planned participants: 1300
  • From 2 Feb 2026 to the primary completion date, 23 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosis of high-risk MDS (HR-MDS) or another hematologic malignancy (e.g., acute myeloid leukemia) before the index date.
  • 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.

Age

  • Have missing key variables, e.g., age or sex.

Other

  • 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.
  • Lack of sufficient clinical history, defined as \<12 months of observable data before the index date.
  • Incomplete or inconsistent clinical information that prevents reliable evaluation of key study variables, including transfusion dependence status, treatment patterns, or outcomes.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
MadridSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.