Chemotherapy-induced Symptomatic Anemia, Lymphomas, Malignant Hemopathies, Myelomas, Solid Tumors
Conditions
Keywords
Chemotherapy-induced anemia, Epoetin biosimilar
Brief summary
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
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.
Interventions
DRUGEpoetin biosimilar
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change and corrected Hemoglobin levels | 6 months | Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observe evolution of the biological indicators | 6 months | Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation |
| 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 | — |
Countries
France
Outcome results
None listed