Myelodysplastic Syndromes (MDS)NCT06581055
A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes
An observational study of Myelodysplastic Syndromes (MDS), run by Bristol-Myers Squibb at 1 site in Taiwan.
Trial summary
This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records. 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 Epoetin Alfa
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2024to 30 Mar 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 participants with myelodysplastic syndromes who were enrolled in the COMMANDS trial (NCT03682536) and discontinued Luspatercept or Epoetin alfa treatment and discontinued the COMMANDS trial.
Who may be able to join
- Participant was enrolled in and discontinued the COMMANDS trial.
- Participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the COMMANDS trial.
- Participant Patient provides informed consent (only where applicable or required by local regulations).
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes Who Discontinued Treatment With Luspatercept or Epoetin Alfa and the COMMANDS Trial
This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.
- Conditions
- Myelodysplastic Syndromes (MDS)
- Being tested
- Luspatercept, Epoetin Alfa
- 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 COMMANDS Trial (NCT03682536) study protocol
Epoetin AlfaDrug
As per COMMANDS Trial (NCT03682536) study protocol
| Study group | Role | What they receive |
|---|---|---|
| Luspatercept | Adult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536). Receives: Drug: Luspatercept | |
| Epoetin alfa | Adult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536). Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant treatment patterns: Type of treatment received
Measured: Up to 24 months
Participant treatment patterns: Duration of treatment received
Measured: Up to 24 months
Participant treatment patterns: Dosage of treatment received
Measured: Up to 24 months
Participant treatment patterns: Dosing route of treatment administration
Measured: Up to 24 months
Participant treatment patterns: Reason for treatment administration
Measured: Up to 24 months
Participant treatment patterns: Time to next line of therapy (LoT)
Measured: Up to 24 months
Participant treatment patterns: Reason for treatment discontinuation
Measured: Up to 24 months
Participant treatment patterns: Type of concomitant medications received
Measured: Up to 24 months
Participant treatment patterns: Start and end dates of concomitant medications received
Measured: Up to 24 months
Secondary outcomes (9)
Participant clinical outcomes: Number of units of red blood cell transfusions received
Measured: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category
Category 1: Transfusion dependent (at least 4 units of red blood cell (RBC) with 8 weeks for hemoglobin (Hb) <9g/dL) Category 2: Transfusion independence (<4 units of RBC with 8 weeks for Hb <9 g/dL)
Measured: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018
IWG 2028 criteria:
- Non-transfused (0 Red Blood Cells [RBC] in 16 weeks)
- Low-transfusion burden (3-7 RBCs in 16 weeks in at least 2 transfusion episodes, maximum 3 in 8 weeks)
- High-transfusion burden (≥8 RBCs in 16 week, ≥4 in 8 weeks)
Measured: Up to 24 months
Participant clinical outcomes: Blood test results
Measured: Up to 24 months
Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status
Measured: Up to 24 months
Number of participants that progressed to high-risk myelodysplastic syndromes (MDS)
Measured: Up to 24 months
Participant clinical outcomes: Participant survival status
Measured: Up to 24 months
Participant clinical outcomes: Date and primary cause of death
Measured: Up to 24 months
Participant clinical characteristics
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: Sponsor decision
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
- 0 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
- NCT06581055
- Sponsor's protocol ID
- CA056-1083
- Status last verified
- Oct 2024
- First submitted
- 29 Aug 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplastic Syndromes Who Discontinued Treatment With Luspatercept or Epoetin Alfa and the COMMANDS Trial
- ClinicalTrials.gov ID
- NCT06581055
- Acronym / sponsor ID
- CA056-1083
- Conditions
- Myelodysplastic Syndromes (MDS)
- Keywords
- Myelodysplastic syndromes (MDS)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 30 Aug 2024 (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 aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luspatercept | – | Drug: LuspaterceptAdult participants treated with and discontinued Luspatercept treatment while enrolled in the COMMANDS trial (NCT03682536). |
| Epoetin alfa | – | Drug: Epoetin AlfaAdult participants treated with and discontinued Epoetin alfa treatment while enrolled in the COMMANDS trial (NCT03682536). |
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 participants with myelodysplastic syndromes who were enrolled in the COMMANDS trial (NCT03682536) and discontinued Luspatercept or Epoetin alfa treatment and discontinued the COMMANDS trial.
Key inclusion criteria (3 listed)
- Participant was enrolled in and discontinued the COMMANDS trial.
- Participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the COMMANDS trial.
- Participant Patient provides informed consent (only where applicable or required by local regulations).
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 COMMANDS Trial (NCT03682536) study protocol | Drug | Luspatercept |
| Epoetin AlfaAs per COMMANDS Trial (NCT03682536) study protocol | Drug | Epoetin alfa |
Primary outcome
Participant treatment patterns: Type of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Duration of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Dosage of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Dosing route of treatment administration
Time frame: Up to 24 months
Participant treatment patterns: Reason for treatment administration
Time frame: Up to 24 months
Participant treatment patterns: Time to next line of therapy (LoT)
Time frame: Up to 24 months
Participant treatment patterns: Reason for treatment discontinuation
Time frame: Up to 24 months
Participant treatment patterns: Type of concomitant medications received
Time frame: Up to 24 months
Participant treatment patterns: Start and end dates of concomitant medications received
Time frame: Up to 24 months
9 secondary outcomes
Participant clinical outcomes: Number of units of red blood cell transfusions received
Time frame: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category
Time frame: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018
Time frame: Up to 24 months
Participant clinical outcomes: Blood test results
Time frame: Up to 24 months
Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status
Time frame: Up to 24 months
Number of participants that progressed to high-risk myelodysplastic syndromes (MDS)
Time frame: Up to 24 months
Participant clinical outcomes: Participant survival status
Time frame: Up to 24 months
Participant clinical outcomes: Date and primary cause of death
Time frame: Up to 24 months
Participant clinical characteristics
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- 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 Taiwan.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 9 Oct 2024. 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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 treatment patterns: Type of treatment received (time frame: Up to 24 months). The study lists 9 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 9 Oct 2024.