An observational study in Myelodysplastic Neoplasms, sponsored by Bristol-Myers Squibb. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
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.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
This study's planned enrollment of 190 is above the median of 150 across 214 observational studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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