Chemotherapy-induced Symptomatic Anaemia, Malignant Lymphomas, Multiple Myeloma, Solid Tumours
Conditions
Keywords
symptomatic anameia
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.
Interventions
None listed
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 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.
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 |
|---|---|---|
| Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics | 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 | — |
| Evaluation of prescriber's therapy plan | 6 months | — |
| Observation of the tolerability profile of Epoetin Zeta | 6 months | — |
Countries
Germany
Outcome results
None listed