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

N/ANot Yet RecruitingNCT07752121

Bristol-Myers Squibb190 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

190

Conditions

Myelodysplastic Neoplasms

Interventions

LuspaterceptDRUG

As per product label

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Mainz, Germany

Outcomes

Primary Outcomes

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

Time frame: Up to Week 24

Secondary Outcomes

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

Time frame: Up to Week 48

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

Time frame: Up to Week 48

Mean change from baseline in hemoglobin concentration

Hemoglobin concentration (g/dL) measured during routine clinical practice.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: Up to 2-years

Time to red blood cell transfusion independence for at least 8 consecutive weeks

Time frame: Up to Week 24

Central 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

Data from ClinicalTrials.gov

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