A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies

November 1, 2016 updated by: Hoffmann-La Roche

Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly

This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4004
      • Plovdiv, Bulgaria, 4000
      • Sofia, Bulgaria, 1756
      • Sofia, Bulgaria, 1757
      • Sofia, Bulgaria, 1784
      • Sofia, Bulgaria, 1527
      • Stara Zagora, Bulgaria, 8000
      • Varna, Bulgaria, 9002
      • Varna, Bulgaria, 9010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults at least 18 years of age
  • Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer
  • Anemia with low erythropoeitin (EPO) levels

Exclusion Criteria:

  • Poorly controlled hypertension
  • Relevant acute or chronic bleeding requiring therapy within 3 months before study drug
  • Treatment with EPO within the last 6 weeks
  • Pregnant or breastfeeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epoetin beta
Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.
Drug: Epoetin beta
Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.
Other Names:
  • NeoRecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate according to hemoglobin level
Time Frame: At Week 4
At Week 4
Transfusion requirement rate
Time Frame: From Weeks 5 to 12
From Weeks 5 to 12
Predictive value of reticulocyte increase
Time Frame: At Week 2
At Week 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to approximately 6 months
Up to approximately 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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