An observational study in Myelodysplastic Neoplasms, sponsored by Bristol-Myers Squibb. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Bristol-Myers Squibb · Observational
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.
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Exclusion Criteria:
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.
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
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Time frame: Up to Week 24
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
Duration of red blood cell transfusion independence (RBC-TI) among participants who achieve an RBC transfusion-free period lasting at least 56 consecutive days.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to Week 48
Number of participants with adverse events
Time frame: 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)
Time frame: 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)
Time frame: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb