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

This study has been terminated.

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by (Responsible Party):

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT01546337

First received: March 1, 2012

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2012

Last Updated Date

March 6, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

response to erythropoietin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01546337 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

endogenous erythropoietin rate [ Time Frame: Within 8 days before inclusion ] [ Designated as safety issue: No ]
hemoglobin rate [ Time Frame: Weeks 0,4,8 and 12 ] [ Designated as safety issue: No ]
Weeks 0 = first ESAs injection
Number of transfusions during the duration of the study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment

Condition ^ICMJE

Myelodysplastic Syndromes
Anemia
Hemopathies

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01546337

Other Study ID Numbers ^ICMJE

CCTIRS908111

Has Data Monitoring Committee

Responsible Party

Rennes University Hospital

Study Sponsor ^ICMJE

Rennes University Hospital

Collaborators ^ICMJE

Ministry of Health, France

Investigators ^ICMJE

Principal Investigator:	Escoffre-Barbe Martine, MD	Rennes University Hospital
Study Chair:	Laviolle Bruno, MD	Rennes University Hospital

Information Provided By

Rennes University Hospital

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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