A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
Purpose
The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.
Condition
- Myelodysplastic Syndromes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. - Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. - Participant must have red blood cell transfusions according to study criteria.
Exclusion Criteria
- Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. - Participant has had a prior allogeneic or autologous stem cell transplant. - Participant has known history or diagnosis of AML. - Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1: erythropoiesis-stimulating agents (ESA) naïve |
|
|
|
Experimental Cohort 2: ESA relapsed or refractory |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160-8500
Kansas City, Kansas 66160-8500
Contact:
Jesus Gonzalez Lugo, Site 0020
913-945-6674
Jesus Gonzalez Lugo, Site 0020
913-945-6674
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb