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

Anemia Clinical Trial

— EPO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01546337
• Other study ID #: CCTIRS908111
• Status: Terminated
• Phase: N/A
• First received: March 1, 2012
• Last updated: March 6, 2012
• Start date: May 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Hemopathies
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
France	Laval Hospital	Laval
France	Rennes University Hospital	Rennes
France	Yves Le Foll Hospital	Saint-Brieuc
France	Saint-Malo Hospital	Saint-Malo
France	Bretagne Atlantic Hospital	Vannes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	endogenous erythropoietin rate		Within 8 days before inclusion	No
Secondary	hemoglobin rate	Weeks 0 = first ESAs injection	Weeks 0,4,8 and 12	No
Secondary	Number of transfusions during the duration of the study		12 weeks	No