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The purpose of this study is to understand the treatment patterns and clinical outcomes of myelodysplastic syndromes patients treated with luspatercept or erythropoiesis-stimulating agents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants treated with first-line (1L) luspatercept treatment |
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| Cohort 2 | Participants treated with first-line (1L) erythropoiesis stimulating agents |
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| Cohort 3 | Participants treated with second-line (2L) luspatercept treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | As per product label |
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| Measure | Description | Time Frame |
|---|---|---|
| Participant baseline demographics | Baseline | |
| Luspatercept dose at treatment initiation | Cohort 1 and 3 only | Baseline |
| Luspatercept dose at treatment discontinuation | Cohort 1 and 3 only | Up to 50 months |
| Luspatercept dose change or escalation or reduction | Cohort 1 and 3 only | Up to 50 months |
| Time from luspatercept initiation to the first occurrence of dose escalation | Cohort 1 and 3 only | Up to 50 months |
| Proportion of participants that discontinued treatment | Up to 50 months | |
| Time from treatment initiation to treatment discontinuation | Up to 50 months | |
| Time from luspatercept/erythropoiesis stimulating agents treatment initiation to initiation of a new treatment for myelodysplastic syndromes | Up to 50 months |
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Inclusion Criteria:
Included in the Flatiron Health Broad Research Network, with 2 or more visits after January 1, 2011
Has evidence of diagnosis with myelodysplastic syndromes (MDS) after Jan 1, 2020, as identified by a natural language processing (NLP)-based machine-learning (ML) model
Has evidence of diagnosis with MDS as identified via structured International Classification of Diseases (ICD) codes:
Age ≥ 18 years at MDS diagnosis
Has either ring sideroblasts positive or negative status, as confirmed by bone marrow aspirate lab results or clinician notes
Has at least one confirmed structured activity more than 8 weeks prior to the index date
Cohort specific inclusion criteria:
First-line (1L) luspatercept cohort
Has evidence of receipt of luspatercept as identified via structured data as evidenced by non-cancelled Medication Order or Medication Administration and confirmed via unstructured data
Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
1L erythropoiesis stimulating agents (ESA) cohort:
Has evidence of receipt of any ESA (i.e., epoetin alfa, darbepoetin alfa, epoetin beta, epoetin alfa-epbx, epoetin zeta, or epoetin beta-methoxy polyethylene glycol) for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
Note: this criterion is included to maximize alignment between the 1L ESA cohort and the 1L luspatercept cohort and minimize bias induced by the dosage requirement in the 1L luspatercept cohort
Second-lin (2L) luspatercept cohort:
Exclusion Criteria:
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The study population will include adult patients identified from the Flatiron Health electronic health record database between January 1, 2011 and August 31, 2024 that have been diagnosed with myelodysplastic syndromes receiving either (a) first-line (1L) luspatercept, (b) 1L erythropoiesis stimulating agents, or (c) second-line luspatercept treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Myers Squibb | Princeton | New Jersey | 08540-4715 | United States |
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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 |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000621232 | luspatercept |
| D006397 | Hematinics |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Erythropoiesis-stimulating agent (ESA) |
| Drug |
As per product label |
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