Chemotherapy induced anaemia under anthracycline therapy D61.10
Conditions
Sponsors
HEXAL AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients at least 18 years old with solid tumours, malignant lymphomas or multiple myeloma, who are treated with an anthracycline containing chemotherapy, have not yet received epoetins in the current chemotherapy line and receive Epoetin alfa HEXAL for the first time in this chemotherapy line for symptomatic anaemia. 2. Therapy with Epoetin alfa HEXAL is planned for two to six chemotherapy cycles. 3. Echocardiography with quantitative assessment of LVEF (in %) has been performed at the start of anthracycline based chemotherapy. 4. At least one further echocardiography with quantitative assessment of LVEF (in %) is planned over the patient's further study participation. 5. Data from cycles with anthracycline containing chemotherapy before the start of epoetin treatment are available for retrospective documentation. 6. Written informed consent of patient covering the retro- and prospective pseudonymous documentation, transmission and analysis of data is available.
Exclusion criteria
Exclusion criteria: 1. Contraindications to Epoetin alfa HEXAL according to the current summary of product characteristics. 2. Patient has not signed the written informed consent form. 3. Patient has participated in the same study earlier. 4. Patient is female and pregnant or breast-feeding. 5. Physician judges the patient as insufficiently compliant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of Epoetin alfa HEXAL, if used for the treatment of chemotherapy (anthracycline) induced anaemia: Blood pressure, haematological laboratory, arterial and/or venous thromboembolic or other cardiovascular events, ADRs (adverse drug reactions) - Documentation over six chemotherapy cycles. Generally the data determined at the start of a cycle and the latest data in a cycle will be documented. Arterial and/or venous thromboembolic or other cardiovascular events and ADRs will be documented irrespective of the time of their appearance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effectiveness of Epoetin alfa HEXAL: Haematological laboratory, doses of Epoetin alfa, number of red blood cell transfusions; Course of anthracycline induced cardiomyopathy under therapy with Epoetin alfa: LVEF, cardiac troponin, natriuretic peptides (as far as routinely evaluated); Epoetin self-application (first cycle): Adequate patient information, experience, performance, symptoms, compliance; Change of quality of life (first and last cycle): LASA scale (Linear Analogue Scale Assessment). Generally the data determined at the start of a cycle and the latest data in a cycle will be documented. All data from examinations not performed routinely (e.g. LVEF) will be documented irrespective of the date of their performance. | — |
Countries
Germany
Contacts
Public ContactDietmar Bulenda
Hexal AG
Outcome results
None listed