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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546337
First Posted: March 7, 2012
Last Update Posted: March 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
  Purpose
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.

Condition
Myelodysplastic Syndromes Anemia Hemopathies

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • response to erythropoietin [ Time Frame: 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:
  • endogenous erythropoietin rate [ Time Frame: Within 8 days before inclusion ]
  • hemoglobin rate [ Time Frame: Weeks 0,4,8 and 12 ]
    Weeks 0 = first ESAs injection

  • Number of transfusions during the duration of the study [ Time Frame: 12 weeks ]

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-myeloid haemopathy or Myelodysplastic Syndromes patients with anemia, who needs ESAs treatment
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546337


Locations
France
Laval Hospital
Laval, France, 53015
Rennes University Hospital
Rennes, France, 35033
Yves Le Foll Hospital
Saint-Brieuc, France, 22027
Saint-Malo Hospital
Saint-Malo, France, 35403
Bretagne Atlantic Hospital
Vannes, France, 56017
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Escoffre-Barbe Martine, MD Rennes University Hospital
Study Chair: Laviolle Bruno, MD Rennes University Hospital
  More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01546337     History of Changes
Other Study ID Numbers: CCTIRS908111
First Submitted: March 1, 2012
First Posted: March 7, 2012
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Rennes University Hospital:
anemia
non-myeloid haemopathy
myelodysplastic syndrome
Erythropoiesis stimulating agents
predictive markers

Additional relevant MeSH terms:
Syndrome
Anemia
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms