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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 30
- Locations
- 5
- Primary Endpoint
- response to erythropoietin
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- endogenous erythropoietin rate(Within 8 days before inclusion)
- hemoglobin rate(Weeks 0,4,8 and 12)
- Number of transfusions during the duration of the study(12 weeks)