Myelodysplastic NeoplasmsLUNISNCT07752121
First-Line Luspatercept in Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms
An observational study of Myelodysplastic Neoplasms, run by Bristol-Myers Squibb at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Neoplasms
- What is being tested?
- Luspatercept
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 3 Sep 2026to 31 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, 55131
Daniel Sasca, Site 0001
About this study
Official title: 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.
- Conditions
- Myelodysplastic Neoplasms
- Being tested
- Luspatercept
- Keywords
- Myelodysplastic Neoplasms, Myelodysplastic Syndromes, MDS, Lower-Risk MDS, RBC Transfusion Dependent, Anemia, Luspatercept, Reblozyl
- Medical subject headings
- Myelodysplastic Syndromes, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Measured: Up to Week 24
Secondary outcomes (14)
Percentage of participants achieving red blood cell transfusion independence for at least 12 consecutive weeks
Measured: Up to Week 48
Percentage of participants achieving red blood cell transfusion independence for at least 16 consecutive weeks
Measured: Up to Week 48
Mean change from baseline in hemoglobin concentration
Hemoglobin concentration (g/dL) measured during routine clinical practice.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 2-years
Time to red blood cell transfusion independence for at least 8 consecutive weeks
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to Week 48
Number of participants with adverse events
Measured: 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)
Measured: 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)
Measured: Day 1, Week 6, Week 12, Week 18, Week 24, Week 36, Week 48, and End of Treatment (up to 2-years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start3 Sep 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752121
- Sponsor's protocol ID
- CA056-1175
- Acronym
- LUNIS
- Status last verified
- Nov 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07752121
- Acronym / sponsor ID
- LUNIS / CA056-1175
- Conditions
- Myelodysplastic Neoplasms
- Keywords
- Myelodysplastic Neoplasms, Myelodysplastic Syndromes, MDS, Lower-Risk MDS, RBC Transfusion Dependent, Anemia, Luspatercept, Reblozyl
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-Line Luspatercept | – | Drug: LuspaterceptAdult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with red blood cell transfusion-dependent lower-risk myelodysplastic neoplasms receiving first-line luspatercept in routine clinical practice in Germany.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuspaterceptAs per product label | Drug | First-Line Luspatercept |
Primary outcome
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks
Time frame: Up to Week 24
14 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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Neoplasms, run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants achieving red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.