Local Institution - 0001
Madrid, 28001, Spain
NCT Number: NCT07465029
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
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Madrid, 28001, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
According to the product label
According to the product label
According to the product label
According to the product label
According to the product label
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Treatment categories include:
Time frame: Up to 5-years
Treatment category received at each line of therapy (first line, second line, third line and beyond), categorized as erythropoiesis-stimulating agents (ESA), luspatercept, hypomethylating agents (HMA), lenalidomide, or conservative management (red blood cell transfusions without disease-modifying therapy). Treatment sequences will be derived from retrospective medical chart abstraction of documented treatment start and stop dates.
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Healthcare resource utilization events, including primary care visits, specialist visits, outpatient visits all-cause hospitalizations, transfusion-related hospitalizations, general laboratory tests, number of prescriptions related to transfusion-dependent lower-risk myelodysplastic syndromes, red blood cell transfusions, use of concomitant medicines related to other comorbidities as documented in participant medical records.
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Time frame: Up to 5-years
Cardiovascular events include: will include acute myocardial infarction or acute coronary syndrome, heart failure decompensation, clinically significant arrhythmias (including atrial fibrillation/flutter and ventricular arrhythmia), stroke or transient ischemic attack, and venous thromboembolism.
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Bristol-Myers Squibb
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.