Treatment Patterns and Outcomes in Patients With Lower-ri... | NCT07073690

Studies
Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in China

NCT07073690

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

May 19, 2026Actual

Enrollment

88Actual

Phase

Not provided

Conditions

Myelodysplastic Syndromes

Interventions

Luspatercept

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2025Actual

Primary Completion Date

May 12, 2026Actual

Completion Date

May 12, 2026Actual

First Submitted Date

Jul 10, 2025

First Submission Date that Met QC Criteria

Jul 10, 2025

First Posted Date

Jul 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2026

Last Update Posted Date

May 19, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants receiving luspatercept treatment			Drug: Luspatercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Luspatercept	Drug	According to the product label	Participants receiving luspatercept treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant red blood cell transfusion independence		Up to 12-weeks
Participants mean hemoglobin (Hb) increase ≥1.5 g/dL		Up to 12-weeks

Secondary Outcomes

Measure	Description	Time Frame
Participant transfusion independence and increase in hemoglobin (Hb)		Up to 48 weeks
Duration of luspatercept monotherapy treatment		Up to 48 weeks
Health Care Resource Utilization (HCRU)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants ≥ 18 years of age.
Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice)
Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status.
Historical documentation of anemia before luspatercept treatment.

Exclusion Criteria:

Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
Received stem cell transplant prior to luspatercept treatment initiation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will comprise of individuals ≥18 years of age diagnosed with Lower-Risk Myelodysplastic Syndromes (LR-MDS) were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhijian Xiao		Tianjin			China

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases