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

Completed

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

• Registration Number: NCT01626547
• Lead Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-22
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2015-07
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change and corrected Hemoglobin levels	6 months	Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of prescriber's therapy plan	6 months
Observation of blood value development	6 months	Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
Evaluation of the profiles of treated patients	6 months
Observation of the tolerability profile of Epoetin Zeta	6 months
Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics	6 months