Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan

November 27, 2025 updated by: Bristol-Myers Squibb
The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Minato-ku
      • Tokyo, Minato-ku, Japan, 107-0052
        • Mebix, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult participants with myelodysplastic syndrome in Japan

Description

Inclusion Criteria:

  • Participants with at least one definitive myelodysplastic syndrome (MDS) diagnosis as per the 10th Revision of the International Statistical Classification of Diseases and Related Health Problems (MDS; ICD10: D46.X) between 01-May-2017 and 31-Jan-2022

  • Participants with confirmed low-risk MDS by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) during baseline as follows:

    • Record of low (0 points) or intermediate-1 (>0 to 1 point) MDS according to IPSS scoring; or
    • Record of very low (≤1.5), low (>1.5-3), or intermediate (>3-4.5) MDS according to IPSS-R scoring; or
    • Mention of very low, low, intermediate, intermediate-1, or lower risk MDS in the Electronic Medical Records (EMR)
  • Participants with a record of a confirmed bone marrow procedure (bone marrow aspiration code D404-00 and/or bone marrow biopsy code D404-02) during baseline period

Exclusion Criteria:

  • Participants not meeting the inclusion criteria
  • Participants <18 years of age at index date
  • Participants who have a look back period <30 days from initial myelodysplastic syndrome diagnosis date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Transfusion dependent
Participants that received ≥2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date.
Procedure: Red blood cell transfusion
≥2 units of red blood cell transfusion
Procedure: Red blood cell transfusion
0 units or <2 units of red blood cell transfusion
Non-transfusion dependent
Participants that received 0 units or <2 units of red blood cell transfusion during the 8 weeks after initial myelodysplastic syndrome diagnosis date.
Procedure: Red blood cell transfusion
≥2 units of red blood cell transfusion
Procedure: Red blood cell transfusion
0 units or <2 units of red blood cell transfusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participant age
Time Frame: At date of diagnosis
At date of diagnosis
Participant sex
Time Frame: At date of diagnosis
At date of diagnosis
Participant weight
Time Frame: At date of diagnosis
At date of diagnosis
Participant height
Time Frame: At date of diagnosis
At date of diagnosis
Participant comorbidities calculated using the Charlson Comorbidity Index (CCI) method
Time Frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
From 30 days prior to diagnosis up to 7 days post to diagnosis
Participant Eastern Cooperative Oncology Group (ECOG) score
Time Frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
From 30 days prior to diagnosis up to 7 days post to diagnosis
Participant International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R) risk category
Time Frame: Date of diagnosis, 6-months and 12 months post-diagnosis
Date of diagnosis, 6-months and 12 months post-diagnosis
Percentage of ring sideroblasts present in participants
Time Frame: Date of bone marrow test; from 30 days prior to diagnosis up to 7 days post to diagnosis
Date of bone marrow test; from 30 days prior to diagnosis up to 7 days post to diagnosis
Percentage of bone marrow blasts present in participants
Time Frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
From 30 days prior to diagnosis up to 7 days post to diagnosis
Histopathology results
Time Frame: From 30 days prior to diagnosis up to 7 days post to diagnosis
From 30 days prior to diagnosis up to 7 days post to diagnosis
Number of red-blood cell transfusions received by participants
Time Frame: Up to 56 days post diagnosis
Up to 56 days post diagnosis
Treatment prescribed by line of therapy
Time Frame: From date of diagnosis, up to 5-years
From date of diagnosis, up to 5-years
Duration of treatment by line of therapy
Time Frame: From date of diagnosis, up to 5-years
From date of diagnosis, up to 5-years
Time between date of diagnosis and treatment
Time Frame: From date of diagnosis to treatment initiation
From date of diagnosis to treatment initiation
Time between date of treatment initiation to treatment discontinuation
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Time between date of diagnosis to date of first red-blood cell transfusion
Time Frame: Date of diagnosis, up to 5-years
Date of diagnosis, up to 5-years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants that achieved red-blood cell transfusion independence during first-line of therapy treatment
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Mean hemoglobin change of participants during first-line of therapy
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Number of transfusion dependant participants achieving re-blood cell transfusion independence for ≥12 weeks with associated concurrent mean hemoglobin increase of ≥1.5 g/dL during first-line of therapy
Time Frame: Week 1-24 post treatment initiation
Week 1-24 post treatment initiation
Number of non-transfusion dependant participants achieving red-blood cell transfusion independence during first-line therapy for ≥24, 48 and 72 weeks
Time Frame: Week 24, 48 and 72 post date of initiation of treatment
Week 24, 48 and 72 post date of initiation of treatment
Time to red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Hematologic Improvement - Erythroid (HI-E) response of transfusion dependant participants receiving first line therapy
Time Frame: From week 1-24 post date of treatment initiation
From week 1-24 post date of treatment initiation
Modified Hematologic Improvement - Erythroid (mHI-E) of transfusion dependant participants receiving first line therapy
Time Frame: From week 1-24 post date of treatment initiation
From week 1-24 post date of treatment initiation
Hematologic Improvement - Erythroid (HI-E) response of non-transfusion dependant participants receiving first line therapy
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Modified Hematologic Improvement - Erythroid (mHI-E) of non-transfusion dependant participants receiving first line therapy
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Time to Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy
Time Frame: From week 1-24 and week 1-48 post date of treatment initiation
From week 1-24 and week 1-48 post date of treatment initiation
Duration of Hematologic Improvement - Erythroid (HI-E) or Modified hematologic improvement - Erythroid (mHI-E) during first-line therapy
Time Frame: From date of treatment initiation to date of treatment discontinuation, up 5-years
From date of treatment initiation to date of treatment discontinuation, up 5-years
Duration of red-blood call transfusion independence of ≥12 weeks for transfusion dependant participants receiving first line therapy
Time Frame: From date of treatment initiation to date of treatment discontinuation, up 5-years
From date of treatment initiation to date of treatment discontinuation, up 5-years
Number of participants diagnosed with Acute Myeloid Leukemia
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Time to Acute Myeloid Leukemia diagnosis
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Overall survival (OS) of participants
Time Frame: 1, 2, 3 and 5-years post treatment initiation
1, 2, 3 and 5-years post treatment initiation
Number of red-blood cell transfusion days per participant
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of red-blood cell units used per transfusion
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of outpatient visits per month
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of hospital admissions
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Length of hospitalization
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Reason for hospitalization
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of emergency department visits
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of Intensive care unit admissions (ICU)
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of outpatient/inpatient medication claims
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Supplemental medication use: Iron chelation use
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Supplemental medication use: Granulocyte-colony stimulating factors (G-CSF)
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Number of hematology tests ordered
Time Frame: Date of treatment initiation, up to 5-years
Date of treatment initiation, up to 5-years
Medical costs
Time Frame: Date of treatment initiation, up to 5-years
Including: cost of red-blood cell transfusion, cost of red-blood cell transfusion administration, cost of erythropoiesis stimulating agents (ESA) medication, cost of ESA administration, cost of iron chelation therapy medications, cost of iron chelation therapy administration, other costs and total costs
Date of treatment initiation, up to 5-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA056-1094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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