Myelodysplastic Syndromes (MDS)NCT06971185
A Study to Evaluate Treatment Patterns and Effectiveness of Luspatercept
An observational study of Myelodysplastic Syndromes (MDS), run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to understand the treatment patterns and clinical outcomes of myelodysplastic syndromes patients treated with luspatercept or erythropoiesis-stimulating agents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes (MDS)
- What is being tested?
- Luspatercept and Erythropoiesis-stimulating agent (ESA)
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population will include adult patients identified from the Flatiron Health electronic health record database between January 1, 2011 and August 31, 2024 that have been diagnosed with myelodysplastic syndromes receiving either (a) first-line (1L) luspatercept, (b) 1L erythropoiesis stimulating agents, or (c) second-line luspatercept treatment.
Who may be able to join
- Included in the Flatiron Health Broad Research Network, with 2 or more visits after January 1, 2011
- Has evidence of diagnosis with myelodysplastic syndromes (MDS) after Jan 1, 2020, as identified by a natural language processing (NLP)-based machine-learning (ML) model
- Has evidence of diagnosis with MDS as identified via structured International Classification of Diseases (ICD) codes:
- International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM): D46.x
- International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM): 238.7x
- Age ≥ 18 years at MDS diagnosis
Show all 19Show fewer
- Has either ring sideroblasts positive or negative status, as confirmed by bone marrow aspirate lab results or clinician notes
- Has at least one confirmed structured activity more than 8 weeks prior to the index date
- Cohort specific inclusion criteria:
- First-line (1L) luspatercept cohort
- Has evidence of receipt of luspatercept as identified via structured data as evidenced by non-cancelled Medication Order or Medication Administration and confirmed via unstructured data
- Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
- 1L erythropoiesis stimulating agents (ESA) cohort:
- Has evidence of receipt of any ESA (i.e., epoetin alfa, darbepoetin alfa, epoetin beta, epoetin alfa-epbx, epoetin zeta, or epoetin beta-methoxy polyethylene glycol) for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
- Note: this criterion is included to maximize alignment between the 1L ESA cohort and the 1L luspatercept cohort and minimize bias induced by the dosage requirement in the 1L luspatercept cohort
- Second-lin (2L) luspatercept cohort:
- Has evidence of receipt of luspatercept as identified via structured data as evidenced by non-cancelled Medication Order or Medication Administration and confirmed via unstructured data
- Has evidence of receipt of at least 1 ESA as evidenced by a non-cancelled medication order or medication administration prior to the date of initial luspatercept receipt
- Has evidence of treatment with luspatercept for at least 12 weeks as evidenced by non-cancelled Medication Orders or Medication Administrations
Who cannot join
- Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team
- Have been exposed to any of the following MDS-related therapy prior to luspatercept initiation in the 1L and 2L settings or ESA initiation in the 1L setting: lenalidomide, azacitidine, decitabine, cedazuridine, eltrombopag, cytarabine, daunorubicin, idarubicin, filgrastim, pegfilgrastim, lipefilgrastim, sargramostim, venetoclax, or has evidence of a stem cell transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol Myers Squibb
Princeton, New Jersey, 08540-4715
About this study
Official title: Treatment Patterns and Effectiveness of Luspatercept in the Real World
The purpose of this study is to understand the treatment patterns and clinical outcomes of myelodysplastic syndromes patients treated with luspatercept or erythropoiesis-stimulating agents
- Conditions
- Myelodysplastic Syndromes (MDS)
- Being tested
- Luspatercept, Erythropoiesis-stimulating agent (ESA)
- Keywords
- Myelodysplastic syndromes (MDS)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
As per product label
Erythropoiesis-stimulating agent (ESA)Drug
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants treated with first-line (1L) luspatercept treatment Receives: Drug: Luspatercept | |
| Cohort 2 | Participants treated with first-line (1L) erythropoiesis stimulating agents Receives: Drug: Erythropoiesis-stimulating agent (ESA) | |
| Cohort 3 | Participants treated with second-line (2L) luspatercept treatment Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant baseline demographics
Measured: Baseline
Luspatercept dose at treatment initiation
Cohort 1 and 3 only
Measured: Baseline
Luspatercept dose at treatment discontinuation
Cohort 1 and 3 only
Measured: Up to 50 months
Luspatercept dose change or escalation or reduction
Cohort 1 and 3 only
Measured: Up to 50 months
Time from luspatercept initiation to the first occurrence of dose escalation
Cohort 1 and 3 only
Measured: Up to 50 months
Proportion of participants that discontinued treatment
Measured: Up to 50 months
Time from treatment initiation to treatment discontinuation
Measured: Up to 50 months
Time from luspatercept/erythropoiesis stimulating agents treatment initiation to initiation of a new treatment for myelodysplastic syndromes
Measured: Up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start22 Nov 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndromes (MDS)Studies 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
- Retrospective
- Enrolment
- 430 participants (actual)
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
- NCT06971185
- Sponsor's protocol ID
- CA056-1124
- Status last verified
- Sep 2026
- First submitted
- 6 May 2025
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Effectiveness of Luspatercept in the Real World
- ClinicalTrials.gov ID
- NCT06971185
- Acronym / sponsor ID
- CA056-1124
- Conditions
- Myelodysplastic Syndromes (MDS)
- Keywords
- Myelodysplastic syndromes (MDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 May 2025 (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.
The purpose of this study is to understand the treatment patterns and clinical outcomes of myelodysplastic syndromes patients treated with luspatercept or erythropoiesis-stimulating agents
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: LuspaterceptParticipants treated with first-line (1L) luspatercept treatment |
| Cohort 2 | – | Drug: Erythropoiesis-stimulating agent (ESA)Participants treated with first-line (1L) erythropoiesis stimulating agents |
| Cohort 3 | – | Drug: LuspaterceptParticipants treated with second-line (2L) luspatercept treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients identified from the Flatiron Health electronic health record database between January 1, 2011 and August 31, 2024 that have been diagnosed with myelodysplastic syndromes receiving either (a) first-line (1L) luspatercept, (b) 1L erythropoiesis stimulating agents, or (c) second-line luspatercept treatment.
Key inclusion criteria (19 listed)
- Included in the Flatiron Health Broad Research Network, with 2 or more visits after January 1, 2011
- Has evidence of diagnosis with myelodysplastic syndromes (MDS) after Jan 1, 2020, as identified by a natural language processing (NLP)-based machine-learning (ML) model
- Has evidence of diagnosis with MDS as identified via structured International Classification of Diseases (ICD) codes:
- Age ≥ 18 years at MDS diagnosis
- Has either ring sideroblasts positive or negative status, as confirmed by bone marrow aspirate lab results or clinician notes
Key exclusion criteria (2 listed)
- Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team
- Have been exposed to any of the following MDS-related therapy prior to luspatercept initiation in the 1L and 2L settings or ESA initiation in the 1L setting: lenalidomide, azacitidine, decitabine, cedazuridine, eltrombopag, cytarabine, daunorubicin, idarubicin, filgrastim, pegfilgrastim, lipefilgrastim, sargramostim, venetoclax, or has evidence of a stem cell transplant
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 | Cohort 1, Cohort 3 |
| Erythropoiesis-stimulating agent (ESA)As per product label | Drug | Cohort 2 |
Primary outcome
Participant baseline demographics
Time frame: Baseline
Luspatercept dose at treatment initiation
Time frame: Baseline
Cohort 1 and 3 only
Luspatercept dose at treatment discontinuation
Time frame: Up to 50 months
Cohort 1 and 3 only
Luspatercept dose change or escalation or reduction
Time frame: Up to 50 months
Cohort 1 and 3 only
Time from luspatercept initiation to the first occurrence of dose escalation
Time frame: Up to 50 months
Cohort 1 and 3 only
Proportion of participants that discontinued treatment
Time frame: Up to 50 months
Time from treatment initiation to treatment discontinuation
Time frame: Up to 50 months
Time from luspatercept/erythropoiesis stimulating agents treatment initiation to initiation of a new treatment for myelodysplastic syndromes
Time frame: Up to 50 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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. This study is not recruiting at the moment.
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 Syndromes (MDS), run by Bristol-Myers Squibb at 1 site in United States.
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 19 inclusion and 2 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: finished, as of the sponsor's last update on 30 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant baseline demographics (time frame: Baseline). The study lists 8 primary outcomes in all. 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 30 Sep 2026.