Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology

Study Overview
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Brief Summary
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The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

Detailed Description
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This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

Official Title
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Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

Conditions
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Solid Tumors, Lymphomas, Chemotherapy-induced Symptomatic Anemia, Malignant Hemopathies, Myelomas

Intervention / Treatment
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* Drug: Epoetin biosimilar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of more than 18 years of age Patients presenting with anemia following chemotherapy Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy -- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle) Patients eligible for epoetin alfa biosimilar treatment Exclusion Criteria: Patients are not receiving chemotherapy Patients already included in an epoetin zeta trial Patients presenting with a contraindication to epoetin zeta Patients presenting with hypersensitivity to the active principle or any of the excipients Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA) Patient with uncontrollable arterial hypertension Patients who cannot receive adequate prophylaxis by antithrombotic agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chemo-induced symptomatic anemia<br> | Drug: Epoetin biosimilar<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change and corrected Hemoglobin levels | Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe evolution of the biological indicators | Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation | 6 months | 
| Study the profiles of treated patients |  | 6 months | 
| Assess the reasons for the prescriber's treatment regimens |  | 6 months | 
| Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics |  | 6 months | 
| Observation of the safety profiles of the Product (Epoetin Alfa) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy-induced anemia, Epoetin biosimilar