Search for Predictive Markers of Efficacy of ESAs in Patients With Non-myeloid Malignancies or Myelodysplastic Syndrome

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01546337

Acronym

EPO

Enrollment

Registered

2012-03-07

Start date

2008-05-31

Completion date

2009-11-30

Last updated

2012-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Hemopathies, Myelodysplastic Syndromes

Keywords

anemia, non-myeloid haemopathy, myelodysplastic syndrome, Erythropoiesis stimulating agents, predictive markers

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
response to erythropoietin	12 weeks	* 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.

Secondary

Measure	Time frame	Description
endogenous erythropoietin rate	Within 8 days before inclusion	—
hemoglobin rate	Weeks 0,4,8 and 12	Weeks 0 = first ESAs injection
Number of transfusions during the duration of the study	12 weeks	—

Countries

France

Outcome results