First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (LUNIS)

A Prospective, Multicenter, Non-Interventional Study Assessing First-line Luspatercept in Anemic Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Neoplasms Requiring Red Blood Cell Transfusions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myelodysplastic Neoplasms
• Intervention / Treatment: Drug: Luspatercept

• Study Type: Observational
• Enrollment (Estimated): 190

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Germany
  • Mainz, Germany
    • Universitätsmedizin der Johannes Gutenberg-Univ. III. Med. Klinik Hämatologie/Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks	Up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Hemoglobin concentration (g/dL) measured during routine clinical practice.	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	Hemoglobin concentration (g/dL) measured during routine clinical practice.	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)
Time from first luspatercept administration to first on-treatment red blood cell transfusion.		Up to 2-years
Time to red blood cell transfusion independence for at least 8 consecutive weeks		Up to Week 24
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.		Up to 2-years
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 84 consecutive days.		Up to 2-years
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 112 consecutive days.		Up to 2-years
Percentage of participants achieving hematologic improvement-erythroid response according to International Working Group (IWG) 2006 criteria	Hematologic improvement-erythroid (HI-E) response is defined as an increase in hemoglobin of at least 1.5 g/dL and/or a reduction of at least 4 red blood cell transfusions during an 8-week period compared with the 8 weeks before treatment, sustained over any consecutive 56-day period	Up to Week 48
Number of participants with adverse events		Up to 2-years
Change from baseline in health-related quality of life assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)		Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Change from baseline in health-related quality of life assessed by Quality of Life in Myelodysplasia Scale (QUALMS)		Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): August 24, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Anemia; MDS; Myelodysplastic Syndromes; Luspatercept; Reblozyl; Myelodysplastic Neoplasms; Lower-Risk MDS; RBC Transfusion Dependent
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Anemia; luspatercept
• Other Study ID Numbers: CA056-1175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No