Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes, Anemia, Hemopathies

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

response to erythropoietin

Outcome Description:

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.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Escoffre-Barbe Martine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rennes University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CCTIRS908111

NCT ID:

NCT01546337

Start Date:

May 2008

Completion Date:

November 2009

Related Keywords:

  • Myelodysplastic Syndromes
  • Anemia
  • Hemopathies
  • anemia
  • non-myeloid haemopathy
  • myelodysplastic syndrome
  • Erythropoiesis stimulating agents
  • predictive markers
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location