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The purpose of this study is to understand the patient profile, utilized treatments, treatment patterns, resulting outcomes, and associated costs relating to luspatercept treatment in patients with lower-risk myelodysplastic syndromes (LR-MDS) or beta-thalassemia in the real-world setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants diagnosed myelodysplastic syndromes receiving luspatercept treatment |
| |
| Cohort 2 | Participants diagnosed beta-thalassemia receiving luspatercept treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant age | Baseline | |
| Participant gender | Baseline | |
| Year of first luspatercept prescription | Baseline | |
| Number of participants by Ring Sideroblast (RS) status (positive/negative/unknown) as measured by bone marrow aspiration | As documented in participant medical charts | Baseline |
| Participant comorbidities | Baseline | |
| Length of follow-up from start of luspatercept treatment initiation until the earliest of the end of continuous enrolment, death, or end of data availability | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that achieve red blood cell (RBC) transfusion independence | Number of participants in Cohort 1 achieving RBC transfusion independence, defined as no RBC transfusions during any consecutive 56-day (8-week) or 84-day (12-week) period within the first 168 days (24 weeks) after the index date, as assessed from transfusion records and medical chart review. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
• None
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The study population will include adult patients diagnosed with myelodysplastic syndromes or beta-thalassemia and treated with luspatercept between January 1, 2020, to June 30, 2022, identified from a German Statutory Health Insurance database
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZEG Berlin, Center for Epidemiology and Health Research | Berlin | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013789 | Thalassemia |
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| ID | Term |
|---|---|
| C000621232 | luspatercept |
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| Total number of RBC units transfused per participant, as assessed from transfusion records and medical chart review, from baseline up to 6 months | Baseline and up to 6 months |
| Time to acute myeloid leukemia transformation | Up to 6 months |
| Time to treatment discontinuation | Up to 6 months |
| D000745 |
| Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |