A Study to Evaluate Treatment Patterns and Effectiveness of Luspatercept

Bristol-Myers Squibb (BMS)

Status

Active, not recruiting

Conditions

Myelodysplastic Syndromes (MDS)

Treatments

Drug: Erythropoiesis-stimulating agent (ESA)

Drug: Luspatercept

Study type

Observational

Funder types

Industry

Identifiers

NCT06971185

CA056-1124

Details and patient eligibility

About

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

Enrollment

430 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
- 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 criteria

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