Myelodysplastic Syndrome (MDS)NCT07008820
Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
An observational study of Myelodysplastic Syndrome (MDS), run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelodysplastic Syndrome (MDS)
- What is being tested?
- Health-related quality of life questionnaires and Qualitative interviews
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- 13 May 2025to 24 Feb 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult participants diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent or adults with suspected myelodysplastic syndromes with unexplained anemia in Japan
Who may be able to join
- The inclusion criteria for the quantitative phase will include either 1 or 2 and all of 3-6:
- Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patrticipants: identified with confirmed via bone marrow aspirate and < 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows:
- Very low, low, or intermediate-risk (score ≤ 3.5) as assessed by IPSS-R
- Low or intermediate-1 (score ≤ 1) as assessed by IPSS
- Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded
- Participants with hemoglobin in the most recent blood test < 10.0 g/dl, or the average of hemoglobin < 10.0g/dl in the most recent 2 blood tests conducted within 30 days prior to enrollment in this study
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- Participants who are ≥ 18 years of age at the time of signing the informed consent form.
- Participants who are able and willing to provide informed consent.
- Participants who are able to complete the protocol requirements.
- For the qualitative phase (approximately 10 participants), the inclusion criteria will also include:
- 1. Participants with severity scores of "moderate" or greater on at least one Patient Global Impression-Severity (PGI-S) item.
Who cannot join
- Patients meeting the following criteria will be excluded:
- Participants who have difficulty obtaining informed consent or execution of this study because of insufficient Japanese language proficiency.
- Participants who are considered to have difficulty answering HRQoL questionnaires and/or responding to questions during cognitive interview
- Participants who received red-blood cell transfusion (RBC-T) within 16 weeks prior to enrollment.
- Note: RBC-T of 1 to 2 units within the 16 weeks prior to enrollment are allowed, provided those 1-2 RBC-T units are administered for an acute event/illness (i.e., surgical procedure, bleeding, infection) or presence of comorbidity (including cardiovascular, pulmonary, cerebrovascular), and not for the treatment of low hemoglobin (with or without symptoms) alone.
- Participants who received prior drug treatment related to anemia; drugs include the following: erythropoiesis stimulating agent, erythroid maturation agent, hypomethylating agent, immunomodulatory drugs, immuno-suppressive agent.
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- Participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to World Health Organization (WHO) 2016 classification (i.e., chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, breakpoint cluster region-Abelson 12, juvenile myelomonocytic leukemia, MDS/MPN unclassifiable).
- Participants with secondary MDS (i.e., MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
- Participants with a known history of diagnosis of acute myeloid leukemia.
- Participants with major surgery within 8 weeks prior to enrollment. Patients must have completely recovered from any previous surgery prior to enrollment.
- Participants with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venus thrombosis within 6 months prior to enrollment. Note: prior superficial thrombophlebitis is not an exclusion criterion.
- Participants who have any condition or receive concomitant medication that confounds the ability to interpret data from the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan
- Conditions
- Myelodysplastic Syndrome (MDS)
- Being tested
- Health-related quality of life questionnaires, Qualitative interviews
- Keywords
- Myelodysplastic Syndrome (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.
Health-related quality of life questionnairesOther
Questionnaires include:
EORTC-QLQ C30 FACT-An PGI-S EQ-5D-5L
Qualitative interviewsOther
For participants that meet eligibility criteria
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Low Risk Myelodysplastic Syndrome erythropoietin stimulating agent naïve and non-transfusion dependent Receives: Other: Health-related quality of life questionnaires; Other: Qualitative interviews | |
| Cohort 2 | Suspected Low Risk Myelodysplastic Syndrome with unexplained anemia Receives: Other: Health-related quality of life questionnaires; Other: Qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ C30) patient reported outcome questionnaire
Measured: Day 1
Participant anemia symptoms as assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) patient reported outcome questionnaire
Measured: Day 1
Symptom severity as assessed by the Patient Global Impression-Severity (PGI-S) patient reported outcome questionnaire
Measured: Day 1
General health status of participants as assessed by the EQ-5D-5L patient reported outcome questionnaire
Measured: Day 1
Participant baseline socio-demographics
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Secondary outcomes (1)
Qualitative interview results
Qualitative interview questions to include questions to understand the participants:
- Experiences of diagnosis and treatment
- Symptoms of anemia
- Quality of life
- Communication with physicians
- Satisfaction with current treatments
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start13 May 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndrome (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
- Prospective
- Enrolment
- 56 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 SquibbBristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008820
- Sponsor's protocol ID
- CA056-1133
- Status last verified
- May 2026
- First submitted
- 27 May 2025
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
- ClinicalTrials.gov ID
- NCT07008820
- Acronym / sponsor ID
- CA056-1133
- Conditions
- Myelodysplastic Syndrome (MDS)
- Keywords
- Myelodysplastic Syndrome (MDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 6 Jun 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.
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Health-related quality of life questionnaires, Other: Qualitative interviewsLow Risk Myelodysplastic Syndrome erythropoietin stimulating agent naïve and non-transfusion dependent |
| Cohort 2 | – | Other: Health-related quality of life questionnaires, Other: Qualitative interviewsSuspected Low Risk Myelodysplastic Syndrome with unexplained anemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult participants diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent or adults with suspected myelodysplastic syndromes with unexplained anemia in Japan
Key inclusion criteria (11 listed)
- The inclusion criteria for the quantitative phase will include either 1 or 2 and all of 3-6:
- Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patrticipants: identified with confirmed via bone marrow aspirate and < 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows:
- Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded
- Participants with hemoglobin in the most recent blood test < 10.0 g/dl, or the average of hemoglobin < 10.0g/dl in the most recent 2 blood tests conducted within 30 days prior to enrollment in this study
- Participants who are ≥ 18 years of age at the time of signing the informed consent form.
Key exclusion criteria (12 listed)
- Participants who have difficulty obtaining informed consent or execution of this study because of insufficient Japanese language proficiency.
- Participants who are considered to have difficulty answering HRQoL questionnaires and/or responding to questions during cognitive interview
- Participants who received red-blood cell transfusion (RBC-T) within 16 weeks prior to enrollment.
- Note: RBC-T of 1 to 2 units within the 16 weeks prior to enrollment are allowed, provided those 1-2 RBC-T units are administered for an acute event/illness (i.e., surgical procedure, bleeding, infection) or presence of comorbidity (including cardiovascular, pulmonary, cerebrovascular), and not for the treatment of low hemoglobin (with or without symptoms) alone.
- Participants who received prior drug treatment related to anemia; drugs include the following: erythropoiesis stimulating agent, erythroid maturation agent, hypomethylating agent, immunomodulatory drugs, immuno-suppressive agent.
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 |
|---|---|---|
| Health-related quality of life questionnairesQuestionnaires include: EORTC-QLQ C30 FACT-An PGI-S EQ-5D-5L | Other | Cohort 1, Cohort 2 |
| Qualitative interviewsFor participants that meet eligibility criteria | Other | Cohort 1, Cohort 2 |
Primary outcome
Participant quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ C30) patient reported outcome questionnaire
Time frame: Day 1
Participant anemia symptoms as assessed by the Functional Assessment of Cancer Therapy - Anemia (FACT-An) patient reported outcome questionnaire
Time frame: Day 1
Symptom severity as assessed by the Patient Global Impression-Severity (PGI-S) patient reported outcome questionnaire
Time frame: Day 1
General health status of participants as assessed by the EQ-5D-5L patient reported outcome questionnaire
Time frame: Day 1
Participant baseline socio-demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
1 secondary outcome
Qualitative interview results
Time frame: Up to 1 month
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 26 May 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
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 Syndrome (MDS), run by Bristol-Myers Squibb at 1 site in Japan.
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 11 inclusion and 12 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 26 May 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 Japan. 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 quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ C30) patient reported outcome questionnaire (time frame: Day 1). The study lists 6 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 26 May 2026.