Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Treatment Patterns and Effectiveness of Luspatercept
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myelodysplastic Syndromes (MDS)
Eligibility:
All Genders
18+ years
Brief Summary
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
Eligibility Criteria
Inclusion
- 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:
- International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM): D46.x
- International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): 238.7x
- 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:
- 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 receipt of at least 1 ESA as evidenced by a non-cancelled medication order or medication administration prior to the date of initial luspatercept receipt
- Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
Exclusion
- Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team
- Have been exposed to any of the following MDS-related therapy prior to luspatercept initiation in the 1L and 2L settings or ESA initiation in the 1L setting: lenalidomide, azacitidine, decitabine, cedazuridine, eltrombopag, cytarabine, daunorubicin, idarubicin, filgrastim, pegfilgrastim, lipefilgrastim, sargramostim, venetoclax, or has evidence of a stem cell transplant
Key Trial Info
Start Date :
November 22 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06971185
Start Date
November 22 2024
End Date
August 1 2025
Last Update
May 14 2025
Active Locations (1)
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1
Bristol Myers Squibb
Princeton, New Jersey, United States, 08540-4715