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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01626547
First received: June 7, 2012
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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™.


Condition
Chemotherapy-induced Symptomatic Anaemia
Solid Tumours
Malignant Lymphomas
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Change and corrected Hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.


Secondary Outcome Measures:
  • Observation of blood value development [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

  • Evaluation of the profiles of treated patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluation of prescriber's therapy plan [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Observation of the tolerability profile of Epoetin Zeta [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: December 2010
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626547

Locations
Germany
Alzey, Germany, 55232
Bad Säckigen, Germany, 79713
Berlin, Germany, 10367
Berlin, Germany, 12627
Berlin, Germany, 13593
Bonn, Germany, 53177
Bonn, Germany, 53123
Borken, Germany, 46325
Brandenburg, Germany, 14770
Chemnitz, Germany, 09113
Cottbus, Germany, 03046
Essen, Germany, 45239
Frankenthal, Germany, 67227
Garbsen, Germany, 30827
Halberstadt, Germany, 38820
Hannover, Germany, 30171
Herne, Germany, 44623
Holzkirchen, Germany, 83607
Krefeld, Germany, 47798
München, Germany, 80638
München, Germany, 81479
Münster, Germany, 48149
Neuss, Germany, 41462
Nürnberg, Germany, 90409
Oberhausen, Germany, 46045
Oberhausen, Germany, 46145
Olpe, Germany, 57462
Oranienburg, Germany, 16515
Paderborn, Germany, 33098
Parchim, Germany, 19370
Plauen, Germany, 08523
Remscheid, Germany, 42859
Rodgau, Germany, 63110
Rötha, Germany, 04571
Schönebeck, Germany, 39218
Soest, Germany, 59494
Stralsund, Germany, 18435
Stuttgart, Germany, 70190
Velbert, Germany, 42551
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01626547     History of Changes
Other Study ID Numbers: ORHEO
Study First Received: June 7, 2012
Last Updated: July 27, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hospira, Inc.:
symptomatic anameia

Additional relevant MeSH terms:
Anemia
Lymphoma
Multiple Myeloma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on September 02, 2015