Lower-risk Myelodysplastic Syndromes (TD LR-MDS)NCT07465029
A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain
An observational study of Lower-risk Myelodysplastic Syndromes (TD LR-MDS), run by Bristol-Myers Squibb at 1 site in Spain.
Trial summary
The purpose of this study is to understand the incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) and describing real-world first-line treatment patterns, healthcare resource utilization, and associated clinical outcomes in adult patients with TD LR-MDS in Spain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower-risk Myelodysplastic Syndromes (TD LR-MDS)
- What is being tested?
- Erythropoiesis-stimulating agents (ESAs), Luspatercept and Lenalidomide
- How many people
- 1,300 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2026to 27 Nov 2026
- 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: The study population will consist of adult participants diagnosed with transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) identified in Spain using the BIG-PAC® database
Who may be able to join
- Age ≥18 years at the time of lower-risk myelodysplastic syndromes (LR-MDS) diagnosis.
- Documented diagnosis of LR-MDS identified through International Classification of Diseases (ICD) 9 codes recorded in medical history. In addition, recorded diagnosis of MDS with an explicitly documented International Prognostic Scoring System (IPSS) category of low or intermediate-1 and/or revised IPSS category of very low or low at or around the index date.
- Evidence of transfusion dependence, defined as receiving ≥2 red blood cell (RBC) units within an 8-week interval, occurring within the selection window (January 1, 2021, to May 31, 2025, or the latest date ensuring detectable follow-up).
- Active participants in BIG-PAC®, defined as ≥1 claim of any kind within 12 months prior to or on the index date (baseline period).
- A minimum of 6 months of follow-up data available after the index date, unless the patient dies earlier
Who cannot join
- Diagnosis of high-risk MDS (HR-MDS) or another hematologic malignancy (e.g., acute myeloid leukemia) before the index date.
- Documented transformation to acute myeloid leukemia (AML) or HR-MDS occurring before initiation of first-line treatment.
- Participation in interventional clinical trials during the period of first-line treatment.
- Presence of anemia secondary to non-MDS-related causes, such as nutritional deficiencies, advanced chronic kidney disease, or active bleeding, when such conditions preclude accurate attribution of transfusion dependence to MDS.
- Lack of sufficient clinical history, defined as <12 months of observable data before the index date.
- Have missing key variables, e.g., age or sex.
- Incomplete or inconsistent clinical information that prevents reliable evaluation of key study variables, including transfusion dependence status, treatment patterns, or outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Retrospective Study on Incidence, First-line Treatment Patterns, and Clinical Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain Using the BIG-PAC® Database
The purpose of this study is to understand the incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) and describing real-world first-line treatment patterns, healthcare resource utilization, and associated clinical outcomes in adult patients with TD LR-MDS in Spain
- Being tested
- Erythropoiesis-stimulating agents (ESAs), Luspatercept, Lenalidomide, Hypomethylating agents (HMAs), Reb blood cell transfusion
- Keywords
- Transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoiesis-stimulating agents (ESAs)Drug
According to the product label
LuspaterceptBiological
According to the product label
LenalidomideDrug
According to the product label
Hypomethylating agents (HMAs)Drug
According to the product label
Reb blood cell transfusionBiological
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Overall cohort of participants with transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) Receives: Drug: Erythropoiesis-stimulating agents (ESAs); Biological: Luspatercept; Drug: Lenalidomide; Drug: Hypomethylating agents (HMAs); Biological: Reb blood cell transfusion | |
| Cohort 2 | Participants that initiated first-line treatment with erythropoiesis-stimulating agents (ESAs) Receives: Drug: Erythropoiesis-stimulating agents (ESAs) | |
| Cohort 3 | Participants that initiated first-line treatment with luspatercept Receives: Biological: Luspatercept | |
| Cohort 4 | Participants that initiated first-line treatment with hypomethylating agents (HMAs) Receives: Drug: Hypomethylating agents (HMAs) | |
| Cohort 5 | Participants that initiated first-line treatment with lenalidomide Receives: Drug: Lenalidomide | |
| Cohort 6 | Participants that receive conservative management (red blood cell transfusions without disease modifying therapy) Receives: Biological: Reb blood cell transfusion | |
| Cohort 7 | Participants with low red-blood cell (RBC) transfusion dependance (<4 RBC per 8 weeks) Receives: Biological: Reb blood cell transfusion | |
| Cohort 8 | Participants with moderate red-blood cell (RBC) transfusion dependance (4-5 RBC per 8 weeks) Receives: Biological: Reb blood cell transfusion | |
| Cohort 9 | Participants with high red-blood cell (RBC) transfusion dependance (≥6 RBC per 8 weeks) Receives: Biological: Reb blood cell transfusion | |
| Cohort 10 | Participants aged <75 years Receives: Drug: Erythropoiesis-stimulating agents (ESAs); Biological: Luspatercept; Drug: Lenalidomide; Drug: Hypomethylating agents (HMAs); Biological: Reb blood cell transfusion | |
| Cohort 11 | Participants aged ≥75 years Receives: Drug: Erythropoiesis-stimulating agents (ESAs); Biological: Luspatercept; Drug: Lenalidomide; Drug: Hypomethylating agents (HMAs); Biological: Reb blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
Measured: Up to 5-years
Prevalence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
Measured: Up to 5-years
Secondary outcomes (23)
Proportion of participants receiving each first-line treatment category
Treatment categories include:
- Erythropoiesis-stimulating agents (ESA)
- Luspateracept
- Hypomethylating agents (HMAs)
- Lenalidomide
- Conservative management (red-blood cell (RBC) transfusions without disease modifying therapy)
Measured: Up to 5-years
Proportion of participants by treatment category at each line of therapy
Treatment category received at each line of therapy (first line, second line, third line and beyond), categorized as erythropoiesis-stimulating agents (ESA), luspatercept, hypomethylating agents (HMA), lenalidomide, or conservative management (red blood cell transfusions without disease-modifying therapy). Treatment sequences will be derived from retrospective medical chart abstraction of documented treatment start and stop dates.
Measured: Up to 5-years
Treatment duration (time from initiation to discontinuation) of first-line treatment
Measured: Up to 5-years
Defined as number of RBC units received per participant per 8-weeks
Measured: Up to 5-years
Number and Rate of Healthcare Resource Utilization Events
Healthcare resource utilization events, including primary care visits, specialist visits, outpatient visits all-cause hospitalizations, transfusion-related hospitalizations, general laboratory tests, number of prescriptions related to transfusion-dependent lower-risk myelodysplastic syndromes, red blood cell transfusions, use of concomitant medicines related to other comorbidities as documented in participant medical records.
Measured: Up to 5-years
Number of participants that achieve hematologic improvement-erythroid (HI-E)
Measured: Up to 5-years
Number of participants that achieve red-blood cell (RBC) transfusion independence (TI)
Measured: Up to 5-years
Number of participants that experience a change in transfusion burden (change in number of red-blood cell units received per 8-weeks)
Measured: Up to 5-years
Number of participants that progress to higher-risk myelodysplastic syndromes (MDS)
Measured: Up to 5-years
Number of participants that progress to acute myeloid leukemia (AML)
Measured: Up to 5-years
Number of participants that do not respond to first-line treatment
Measured: Up to 5-years
Number of participants that experience loss of response/secondary failure after an initial hematologic response
Measured: Up to 5-years
Cause of death
Measured: Up to 5-years
Serious adverse events (SAEs)
Measured: Up to 5-years
Number of serious cardiovascular events requiring emergency room visit or hospitalization
Cardiovascular events include: will include acute myocardial infarction or acute coronary syndrome, heart failure decompensation, clinically significant arrhythmias (including atrial fibrillation/flutter and ventricular arrhythmia), stroke or transient ischemic attack, and venous thromboembolism.
Measured: Up to 5-years
Participant age
Measured: Baseline
Participant sex
Measured: Baseline
Year of first-line treatment initiation
Measured: Baseline
Participant Body mass index (BMI)
Measured: Baseline
Participant Charlson Comorbidity Index (CCI) score
Measured: Baseline
Participant Charlson Comorbidity Index (CCI) individual comorbidities
Measured: Baseline
Number of comorbidities
Measured: Baseline
Smoking status
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start2 Feb 2026
- Primary completion23 Apr 2026
- Study completion27 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower-risk Myelodysplastic Syndromes (TD LR-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
- 1,300 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
- NCT07465029
- Sponsor's protocol ID
- CA056-1172
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study on Incidence, First-line Treatment Patterns, and Clinical Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in Spain Using the BIG-PAC® Database
- ClinicalTrials.gov ID
- NCT07465029
- Acronym / sponsor ID
- CA056-1172
- Keywords
- Transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 27 Nov 2026 (estimated)
- First posted
- 11 Mar 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.
The purpose of this study is to understand the incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) and describing real-world first-line treatment patterns, healthcare resource utilization, and associated clinical outcomes in adult patients with TD LR-MDS in Spain
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Erythropoiesis-stimulating agents (ESAs), Biological: Luspatercept, Drug: Lenalidomide, Drug: Hypomethylating agents (HMAs), Biological: Reb blood cell transfusionOverall cohort of participants with transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) |
| Cohort 2 | – | Drug: Erythropoiesis-stimulating agents (ESAs)Participants that initiated first-line treatment with erythropoiesis-stimulating agents (ESAs) |
| Cohort 3 | – | Biological: LuspaterceptParticipants that initiated first-line treatment with luspatercept |
| Cohort 4 | – | Drug: Hypomethylating agents (HMAs)Participants that initiated first-line treatment with hypomethylating agents (HMAs) |
| Cohort 5 | – | Drug: LenalidomideParticipants that initiated first-line treatment with lenalidomide |
| Cohort 6 | – | Biological: Reb blood cell transfusionParticipants that receive conservative management (red blood cell transfusions without disease modifying therapy) |
| Cohort 7 | – | Biological: Reb blood cell transfusionParticipants with low red-blood cell (RBC) transfusion dependance (<4 RBC per 8 weeks) |
| Cohort 8 | – | Biological: Reb blood cell transfusionParticipants with moderate red-blood cell (RBC) transfusion dependance (4-5 RBC per 8 weeks) |
| Cohort 9 | – | Biological: Reb blood cell transfusionParticipants with high red-blood cell (RBC) transfusion dependance (≥6 RBC per 8 weeks) |
| Cohort 10 | – | Drug: Erythropoiesis-stimulating agents (ESAs), Biological: Luspatercept, Drug: Lenalidomide, Drug: Hypomethylating agents (HMAs), Biological: Reb blood cell transfusionParticipants aged <75 years |
| Cohort 11 | – | Drug: Erythropoiesis-stimulating agents (ESAs), Biological: Luspatercept, Drug: Lenalidomide, Drug: Hypomethylating agents (HMAs), Biological: Reb blood cell transfusionParticipants aged ≥75 years |
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 consist of adult participants diagnosed with transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) identified in Spain using the BIG-PAC® database
Key inclusion criteria (5 listed)
- Age ≥18 years at the time of lower-risk myelodysplastic syndromes (LR-MDS) diagnosis.
- Documented diagnosis of LR-MDS identified through International Classification of Diseases (ICD) 9 codes recorded in medical history. In addition, recorded diagnosis of MDS with an explicitly documented International Prognostic Scoring System (IPSS) category of low or intermediate-1 and/or revised IPSS category of very low or low at or around the index date.
- Evidence of transfusion dependence, defined as receiving ≥2 red blood cell (RBC) units within an 8-week interval, occurring within the selection window (January 1, 2021, to May 31, 2025, or the latest date ensuring detectable follow-up).
- Active participants in BIG-PAC®, defined as ≥1 claim of any kind within 12 months prior to or on the index date (baseline period).
- A minimum of 6 months of follow-up data available after the index date, unless the patient dies earlier
Key exclusion criteria (7 listed)
- Diagnosis of high-risk MDS (HR-MDS) or another hematologic malignancy (e.g., acute myeloid leukemia) before the index date.
- Documented transformation to acute myeloid leukemia (AML) or HR-MDS occurring before initiation of first-line treatment.
- Participation in interventional clinical trials during the period of first-line treatment.
- Presence of anemia secondary to non-MDS-related causes, such as nutritional deficiencies, advanced chronic kidney disease, or active bleeding, when such conditions preclude accurate attribution of transfusion dependence to MDS.
- Lack of sufficient clinical history, defined as <12 months of observable data before the index date.
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 |
|---|---|---|
| Erythropoiesis-stimulating agents (ESAs)According to the product label | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 2 |
| LuspaterceptAccording to the product label | Biological | Cohort 1, Cohort 10, Cohort 11, Cohort 3 |
| LenalidomideAccording to the product label | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 5 |
| Hypomethylating agents (HMAs)According to the product label | Drug | Cohort 1, Cohort 10, Cohort 11, Cohort 4 |
| Reb blood cell transfusionAccording to the product label | Biological | Cohort 1, Cohort 10, Cohort 11, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
Time frame: Up to 5-years
Prevalence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS)
Time frame: Up to 5-years
23 secondary outcomes
Proportion of participants receiving each first-line treatment category
Time frame: Up to 5-years
Proportion of participants by treatment category at each line of therapy
Time frame: Up to 5-years
Treatment duration (time from initiation to discontinuation) of first-line treatment
Time frame: Up to 5-years
Defined as number of RBC units received per participant per 8-weeks
Time frame: Up to 5-years
Number and Rate of Healthcare Resource Utilization Events
Time frame: Up to 5-years
Number of participants that achieve hematologic improvement-erythroid (HI-E)
Time frame: Up to 5-years
Number of participants that achieve red-blood cell (RBC) transfusion independence (TI)
Time frame: Up to 5-years
Number of participants that experience a change in transfusion burden (change in number of red-blood cell units received per 8-weeks)
Time frame: Up to 5-years
Number of participants that progress to higher-risk myelodysplastic syndromes (MDS)
Time frame: Up to 5-years
Number of participants that progress to acute myeloid leukemia (AML)
Time frame: Up to 5-years
Number of participants that do not respond to first-line treatment
Time frame: Up to 5-years
Number of participants that experience loss of response/secondary failure after an initial hematologic response
Time frame: Up to 5-years
Cause of death
Time frame: Up to 5-years
Serious adverse events (SAEs)
Time frame: Up to 5-years
Number of serious cardiovascular events requiring emergency room visit or hospitalization
Time frame: Up to 5-years
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Year of first-line treatment initiation
Time frame: Baseline
Participant Body mass index (BMI)
Time frame: Baseline
Participant Charlson Comorbidity Index (CCI) score
Time frame: Baseline
Participant Charlson Comorbidity Index (CCI) individual comorbidities
Time frame: Baseline
Number of comorbidities
Time frame: Baseline
Smoking status
Time frame: Baseline
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 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 Lower-risk Myelodysplastic Syndromes (TD LR-MDS), run by Bristol-Myers Squibb at 1 site in Spain.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 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 Spain. 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?
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?
Incidence of transfusion dependent lower-risk myelodysplastic syndromes (TD LR-MDS) (time frame: Up to 5-years). The study lists 2 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 1 Oct 2026.