Asia Myelodysplastic Syndrome (MDS) Registry

The purpose of this study is to provide a contemporary view and offer invaluable insights into the demographic profiles, clinical characteristics, treatments, and real-world outcomes of individuals with myelodysplastic syndromes (MDS) in Asia.

Study Overview

• Status: Not yet recruiting
• Conditions: Myelodysplastic Syndromes (MDS)
• Intervention / Treatment: Drug: Prescribed treatments for myelodysplastic syndromes (MDS)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Local Institution - 0003
    • Contact: Site 0003
• South Korea
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Local Institution - 002
      • Contact: Site 002
• Taiwan
  • Taipei, Taiwan, 100229
    • Local Institution - 0001
    • Contact: Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The registry will include adults who were/are newly diagnosed with myelodysplastic syndromes (MDS) in Asia (Singapore, South Korea and Taiwan).

Description

Inclusion Criteria:

Retrospective enrolment of Myelodysplastic Syndrome (MDS) participants:

• Aged at least 18 years at initial diagnosis of MDS
• Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 January 2019 and 31 December 2022; and
• Diagnosed with MDS within 100 days from the date of diagnostic bone marrow (BM) aspirate

Inclusion criteria for the prospective enrolment of MDS participants:

• Aged at least 18 years at initial diagnosis of MDS; and
• Diagnosed with MDS according to World Health Organization (WHO) 2008, WHO 2016, or WHO 2022 criteria between 1 October 2025 and 30 September 2026; and
• Diagnosed with MDS within 100 days from the date of diagnostic BM aspirate

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Participants diagnosed with myelodysplastic syndromes (MDS)	Drug: Prescribed treatments for myelodysplastic syndromes (MDS); According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant age	Baseline
Participant sex	Baseline
Participant height	Baseline
Participant weight	Baseline
Participant smoking status	Baseline
Participant drinking status	Baseline
Participant race	Baseline
Participant body mass index (BMI)	Baseline
Family history of MDS or other hematopoietic cancers	Baseline
Participant myelodysplastic syndromes diagnosis information	Baseline
Participant Eastern Cooperative Oncology Group (ECOG) Performance status at diagnosis	Baseline
Participant comorbidities at diagnosis	Baseline
Participant Charlson comorbidity index (CCI) score at diagnosis	Baseline
Prior clinical diagnosis of other cancers	Baseline
Prior clinical diagnosis of hematological diseases	Baseline
Anemia status at diagnosis	Bseline
Thrombocytopenia status at diagnosis	Baseline
Neutropenia status at diagnosis	Baseline
Iron overload status at diagnosis	Baseline
Red blood cell (RBC) transfusion dependence status at diagnosis	Baseline
International Prognostic Scoring System (IPSS) score at diagnosis	Baseline
Revised International Prognostic Scoring System (IPSS-R) score at diagnosis	Baseline
Molecular International Prognostic Scoring System (IPSS-M) score at diagnosis	Baseline
Bone marrow aspirate results	Baseline and up to 2-years
Presence of dysplasia	Baseline and up to 2-years
Cytogenetic test results	Baseline and up to 2-years
Mutation test results at diagnosis	Baseline
Complete blood count test results at diagnosis	Baseline
Mean corpuscular volume (MCV)	Baseline and up to 2-years
C-reactive protein (CRP)	Baseline and up to 2-years
Serum ferritin (SF) level	Baseline and up to 2-years
Serum erythropoietin levels	Baseline and up to 2-years
Lactate dehydrogenase (LDH)	Baseline and up to 2-years

Secondary Outcome Measures

Outcome Measure	Time Frame
Initial treatment received following diagnosis	Baseline
Prior treatments and concomitant medications received	Baseline
Subsequent treatments received	Up to 2-years
Time from diagnosis to treatment initiation	Baseline
Treatment duration	Up to 2-years
Real-world overall survival (rwOS)	Baseline and up to 2-years
Time to disease-risk progression (per IPSS-R)	Baseline and up to 2-years
Time to acute myeloid leukemia (AML) progression	Baseline and up to 2-years
Time to iron overload	Baseline and up to 2-years
Overall response rate (ORR)	Baseline and up to 2-years
Duration of response (DOR)	Baseline and up to 2-years
Real-world relapse-free survival (rwRFS)	Baseline and up to 2-years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb; Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Myelodysplastic syndromes (MDS)
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes
• Other Study ID Numbers: CA056-1131

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
• product manufactured in and exported from the U.S.: Yes