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

Terminated

• Conditions: Myelodysplastic Syndromes; Anemia; Hemopathies

• Registration Number: NCT01546337
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-11
• Status Verified: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Last Update Submitted: 2012-03-06
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Laval Hospital; 🇫🇷 Laval, France

Yves Le Foll Hospital; 🇫🇷 Saint-Brieuc, France

Bretagne Atlantic Hospital; 🇫🇷 Vannes, France

Rennes University Hospital; 🇫🇷 Rennes, France

Saint-Malo Hospital; 🇫🇷 Saint-Malo, France