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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chemotherapy-induced Symptomatic Anaemia, Solid Tumors, Malignant Lymphomas, Multiple Myeloma

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Trial Information

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


Inclusion Criteria:



- Patients are 18 years of age or over.

- 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

- Patients can be recruited at any time (from the first to the final chemotherapy
cycle.)

- Patients would be suited for a course of treatment with RetacritTM (epoetin zeta)

Exclusion Criteria:

- Patients are not undergoing chemotherapy.

- Patients have already taken part in a RetacritTM study.

- The patients have contraindications to Retacrit(TM)

- Patients have hypersensitivity to the active principle or to one of the excipients.

- The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA)

- Uncontrollable hypertension

- An adequate prophylaxis against thrombosis is not practicable

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change and corrected Hemoglobin levels

Outcome Description:

Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ORHEO

NCT ID:

NCT01626547

Start Date:

October 2010

Completion Date:

March 2013

Related Keywords:

  • Chemotherapy-induced Symptomatic Anaemia
  • Solid Tumors
  • Malignant Lymphomas
  • Multiple Myeloma
  • symptomatic anameia
  • Anemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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