Myelodysplastic syndrome
Conditions
Brief summary
Primary endpoint: composite of achievement of RBC-TI for 8-weeks with a concurrent mean Hb increase of ≥ 1 g/dL from Week 1 to Week 24.
Detailed description
Main secondary efficacy endpoints: mean change in total RBC units transfused over a fixed 16 week period from Week 9 to Week 24 and from Week 33 to Week 48. Time from first dose to first onset of RBC TI ≥ 8, 12, and 16 weeks, Maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period, Main secondary safety endpoint is the type, frequency, severity of AEs, and relationship of adverse events (AEs) to luspatercept from screening to 6 weeks (42-days) post last dose and from Week 1 to Week 48
Interventions
Sponsors
Celgene Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: composite of achievement of RBC-TI for 8-weeks with a concurrent mean Hb increase of ≥ 1 g/dL from Week 1 to Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary efficacy endpoints: mean change in total RBC units transfused over a fixed 16 week period from Week 9 to Week 24 and from Week 33 to Week 48. Time from first dose to first onset of RBC TI ≥ 8, 12, and 16 weeks, Maximum duration of RBC-TI for participants who achieve RBC TI ≥ 8- and 16-week period, Main secondary safety endpoint is the type, frequency, severity of AEs, and relationship of adverse events (AEs) to luspatercept from screening to 6 weeks (42-days) post last dose and from Week 1 to Week 48 | — |
Countries
Belgium, Czechia, France, Germany, Italy, Poland, Spain
Outcome results
None listed