Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and abone marrow blast count of < 5%, Refractory or intolerant to, or ineligible for, prior ESA treatment and for prior lenalidomide treatment and who require RBC transfusions.
Conditions
Brief summary
RBC Transfusion Independence (for 8 weeks in the first 24 weeks)
Detailed description
Safety and tolerability of Luspatercept, RBC-TI at 48 weeks and end of the study, Duration of RBC-TI, Reduction in RBC transfusions, Increase in hemoglobin, Change in quality of life scores (ie. QOL-E and HM-PRO), Change in Serum Ferritin, Change in iron chelation therapy use, Time to RBC TI
Interventions
Sponsors
Associazione Qol-One
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RBC Transfusion Independence (for 8 weeks in the first 24 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of Luspatercept, RBC-TI at 48 weeks and end of the study, Duration of RBC-TI, Reduction in RBC transfusions, Increase in hemoglobin, Change in quality of life scores (ie. QOL-E and HM-PRO), Change in Serum Ferritin, Change in iron chelation therapy use, Time to RBC TI | — |
Countries
Italy
Outcome results
None listed