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

Hospira

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01626547

ORHEO

Details and patient eligibility

About

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™.

Full description

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.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.