An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy

This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.

Study Overview

• Status: Completed
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1125
  • Budapest, Hungary, 1088
  • Budapest, Hungary, 1529
  • Budapest, Hungary, 1441
  • Kaposvár, Hungary, 7400
  • Szolnok, Hungary, 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Anemic patients with non-myeloid malignancy

Description

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Presence of solid-tumor or non-myeloid malignancy
• Patients receiving chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• Patients require NeoRecormon

Exclusion Criteria:

• Hypersensitivity to the drug
• Uncontrolled hypertension
• Female patients if pregnant and/or lactating

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8	Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.	Baseline to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Hemoglobin Level up to Week 16	The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.	Baseline, Week 4, Week 8, Week 12, and Week 16
Percentage of Red Blood Cell Transfusion-free Participants	Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.	Up to Week 16
Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy	Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as "1" denotes an effect on the response of treatment with or without iron replacement therapy. Response value as "0" denotes no effect on the response of treatment with or without iron replacement therapy.	Up to Week 16
Number of Participants With Adverse Events and Serious Adverse Events	An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.	Up to Week 16

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ML25362