A Study to Evaluate Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Patients With Lower-Risk Myelodysplastic Syndromes Treated With Luspatercept

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Myelodysplastic Syndromes

Treatments: Drug: Luspatercept

Study type: Observational

Funder types: Industry

Identifiers

NCT07075406

CA056-1043

Details and patient eligibility

About

The purpose of this study is to understand the treatment use of luspatercept in adults diagnosed with lower-risk myelodysplastic syndromes

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of primary myelodysplastic syndromes (MDS) with lower-risk status as measured by the International Prognostic Scoring System (IPSS) or the Revised International Prognostic Scoring System (IPSS-R) at the time of diagnosis

  • IPSS risk level: low, intermediate-1 (level-1 risk)
  • IPSS-R risk level: very low, low, intermediate

• Initiated luspatercept for treatment of Lower-Risk (LR)-MDS after the initial availability in each country of interest

  • US: after April 2020
  • Germany: after June 2020
  • Spain: after June 2020
  • France: after June 202
  • Canada: after February 2021

• The participant has a potential follow-up of at least 6 months from the index date (except death)

• The participant is aged 18 years or older at the index date

• The participant has a complete medical record or history for at least 12 months before the index date (or up to the date of initial LR-MDS diagnosis if duration between initial diagnosis and index date is less than 12 months)

Exclusion criteria

• Received luspatercept as part of a clinical trial
• The participant has evidence of other malignant neoplasms prior to diagnosis of MDS, except disease free for ≥ 5 years at time of MDS diagnosis, basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histologic finding of prostate cancer (stage T1a or T1b)
• The participant has a history of Acute Myeloid Leukemia prior to MDS diagnosis
• The participant has participated in clinical trials for specific treatments related to treatment of MDS

Trial design

250 participants in 1 patient group

Participants receiving luspatercept treatment

Treatment:

Drug: Luspatercept