First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms

NCT07752121 | Not Yet Recruiting FDA Drug

• 1 other identifier: CA056-1175
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

This study will observe adults with lower-risk myelodysplastic neoplasms (MDS) who have anemia requiring regular red blood cell transfusions and who are prescribed first-line luspatercept as part of routine medical care. The study will follow participants for up to 2 years to understand how often treatment leads to periods without transfusions, changes in hemoglobin levels, health-related quality of life, and safety outcomes. Information on treatment use and outcomes in routine clinical practice in Germany will also be collected.

Conditions

Myelodysplastic Neoplasms

Keywords

Myelodysplastic Neoplasms; Myelodysplastic Syndromes; MDS; Lower-Risk MDS; RBC Transfusion Dependent; Anemia; Luspatercept; Reblozyl

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks

  Up to Week 24

Secondary Outcomes (14)

• Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks

  Up to Week 48

• Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks

  Up to Week 48

• Mean change from baseline in hemoglobin concentration

  Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

• Percentage of participants with hemoglobin increase of at least 1.5 g/dl from baseline

  Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

• Percentage of participants achieving >50% reduction in transfusion burden compared with baseline

  Day 1 through Week 24, Week 48, End of Treatment (up to 2-years), and End of Study (up to 2-years)

Study Arms (1)

First-Line Luspatercept

Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.

Drug: Luspatercept

Interventions

Luspatercept DRUG

As per product label

First-Line Luspatercept

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

Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.

You may qualify if:

• Males and females ≥18 years of age at enrollment.
• Documented diagnosis of myelodysplastic neoplasms according to World Health Organisation (WHO) 2022 or WHO 2016 classification meeting International Prognostic Scoring System-Revised (IPSS-R) criteria for very low-, low-, or intermediate-risk disease.
• Documented red blood cell transfusion dependence of ≥2 units of red blood cells within the 8 weeks preceding Day 1 treatment initiation.
• First-line treatment based on the approved luspatercept label and decision for treatment with luspatercept as assessed by the treating physician prior to study participation
• Provision of written informed consent.

You may not qualify if:

• Contraindication according to the Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC).
• Parallel participation in an interventional clinical trial (except follow-up phase as specified in protocol).
• Patients who have completed their participation in an interventional clinical trial or who are not receiving any study drug anymore and who are only in the follow-up phase can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.
• Concurrent malignancy requiring treatment.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie

Mainz, Germany

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

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

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 7, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)