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

NCT07075406 | Completed FDA Drug

• 1 other identifier: CA056-1043
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myelodysplastic Syndromes

Keywords

Lower-risk myelodysplastic syndromes (LR-MDS)

Outcome Measures

Primary Outcomes (3)

• Participant baseline demographics

  Baseline

• Participant baseline clinical characteristics

  Baseline

• Participant treatment history

  Baseline

Secondary Outcomes (9)

• Number of participants receiving myelodysplastic syndromes (MDS) -directed treatment modalities

  Up to 12 months

• Systemic therapy agent or combination of agents received by participants

  Up to 12 months

• Treating clinicians' rationale for prescribing treatment(s)

  Up to 12 months

• Time to treatment discontinuation

  Up to 12 months

• Duration of treatment

  Up to 12 months

Study Arms (1)

Participants receiving luspatercept treatment

Drug: Luspatercept

Interventions

Luspatercept DRUG

According to product label

Participants receiving luspatercept treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults diagnosed with lower-risk myelodysplastic syndromes (LR-MDS) who have been initiated luspatercept treatment in US, Germany, Spain, France and Canada

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

RTI Health Solutions

Research Triangle Park, North Carolina, 27709-2194, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)