Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

Study Overview
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Brief Summary
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The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

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

Official Title
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Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study

Conditions
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Chemotherapy-induced Symptomatic Anaemia, Solid Tumours, Malignant Lymphomas, Multiple Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥18 years . Patients present with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their 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 study. Patients presenting with the contraindications to epoetin zeta. Patients presenting with the hypersensitivity to the active substance or any of the excipients. The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA). Patients with uncontrolled 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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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 |
| --- | --- | --- |
| Observation of blood value development | Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation | 6 months | 
| Evaluation of the profiles of treated patients |  | 6 months | 
| Evaluation of prescriber's therapy plan |  | 6 months | 
| Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics |  | 6 months | 
| Observation of the tolerability profile of Epoetin Zeta |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic anameia