Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to
treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist
of a 14-day screening period followed by a maximum 24-week treatment period and a final
visit. Darbepoetin alfa will be initiated at a dose of 300 mcg QW SC over a period of 8
weeks. After 8 weeks, erythroid response will be evaluated, and treatment algorithm adapted
The study treatment period will last for a maximum of 24 weeks. The treatment will end at
the start of week 24. If the scheduled 24-week treatment period is not completed, it will
end during the week of the last administration of the study drug.
The follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the
last dose of darbepoetin alfa.
Subjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients achieving an erythroid response during the 24-week treatment period.
weeks 8; 12; 16 and 24
Ana M Villegas, MD
Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon
Spain: Spanish Agency of Medicines