Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Phase 3 Completed 147 enrolled Amgen

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

Timeline

Start: 2011-12-21
Primary completion: 2015-02-11
Completion: 2017-09-14

Outcome

Met primary endpoint

registry Placebo vs Darbepoetin Alfa; p = 0.008; Chi-squared NCT01362140 ↗

release “Phase 3 Aranesp ® (darbepoetin alfa) ARCADE trial met its primary endpoint” amgen.com ↗

Publications

Background Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, Slama B, Badre S, Gasal E, Mehta B, Franklin J. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017 Sep;31(9):1944-1950. doi: 10.1038/leu.2017.192. Epub 2017 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darbepoetin alfa	Protein / enzyme biologic	500 ug	Subcutaneous