Clinical trial NCT01546337: Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myelodysplastic Syndromes
Anemia
Hemopathies
Keywords: anemia
non-myeloid haemopathy
myelodysplastic syndrome
Erythropoiesis stimulating agents
predictive markers
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment

Brief summary: 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. 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18
* patients with non-myeloid haemopathy receiving chemotherapy or myelodysplastic syndrome
* indication of ESAs therapy with Hb \< 11g/dl

Exclusion Criteria:

* uncontrolled hypertension
* anemia due to deficiency
* pregnant and lactating women
* patient who received treatment with erythropoiesis-activating factors in the two months preceding inclusion

Primary outcomes:
measure: response to erythropoietin
timeFrame: 12 weeks
Secondary outcomes:
measure: endogenous erythropoietin rate
timeFrame: Within 8 days before inclusion
measure: hemoglobin rate
timeFrame: Weeks 0,4,8 and 12
measure: Number of transfusions during the duration of the study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Laval
country: France
facility: Laval Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint-Brieuc
country: France
facility: Yves Le Foll Hospital
city: Saint-Malo
country: France
facility: Saint-Malo Hospital
city: Vannes
country: France
facility: Bretagne Atlantic Hospital
Study officials:
affiliation: Rennes University Hospital
name: Escoffre-Barbe Martine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Laviolle Bruno, MD
role: STUDY_CHAIR
References: