Search for Predictive Markers of Efficacy of Epoetin Beta (NEORECORMON) in the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Chemotherapy or Myelodysplastic Syndrome
Anemia is common among cancer patients and the treatment of choice is now
Erythropoiesis-Stimulating Agents (ESAs). However, some patients do not respond to
treatment. Thus, only 50-60% of patients with multiple myeloma or non-Hodgkin lymphoma
respond to ESAs. The purpose of this study is to evaluate the predictive value of endogenous
erythropoietin rate on the response to erythropoietin beta. First, by confirming the
predictive value of endogenous erythropoietin observed / predicted ratio on this response.
Then if it is confirmed by establishing the optimal value of this ratio.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
response to erythropoietin
Complete response : increase of 2g/dl of erythropoietin rate or stopping of transfusion requirements. Partial response : increase of 1 to 2g/dl rate of erythropoietin or 50% reduction of transfusion requirements.
12 weeks
No
Escoffre-Barbe Martine, MD
Principal Investigator
Rennes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CCTIRS908111
NCT01546337
May 2008
November 2009
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