Back to resultsA Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 4
Locations
Venezuela
Study Type
Interventional
Intervention
Epoetin Beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
- Anemia at Screening Visit
Exclusion Criteria:
- Transfusion of red blood cells within 2 months of study drug
- Treatment-resistant hypertension
- Acute or chronic bleeding (requiring therapy) within 3 months of study drug
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epoetin Beta - 30000 IU
Arm Description
Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
Outcomes
Primary Outcome Measures
Hemoglobin levels at 16 weeks
Secondary Outcome Measures
Serum Iron, Ferritin and Transferrin Levels
Time to Global Response
Percentage of Participants with a Positive Response
Quality of Life in Relation to Grade of Anemia
Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Tolerability - Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02608060
Brief Title
A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B
Official Title
Open Multicentric Study to Assess the Hematopoyetic Response in Terms of Increase of Hemoglobin Levels of Patients With Anemia Related to Non- Hodgkin Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma, Treated With Erythropoietin B (Recormon) Using Pre-filled Syringe With 30000 IU, as Well as to Quantify the Risk Factors of Anemia and Its Impact on Quality of Life Related to Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to poor enrollment this study was terminated prematurely.
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will examine the efficacy, safety and effect on hemoglobin levels, of once weekly subcutaneous injections of epoetin beta (30,000 IU) in anemic participants with non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma. The anticipated study duration is 4 months, and the target sample size is 30 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin Beta - 30000 IU
Arm Type
Experimental
Arm Description
Dosage at Initiation: Subcutaneous injection of 30000 IU epoetin beta administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
Intervention Type
Drug
Intervention Name(s)
Epoetin Beta
Other Intervention Name(s)
Recormon
Intervention Description
Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 g/dL versus baseline.
Primary Outcome Measure Information:
Title
Hemoglobin levels at 16 weeks
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Serum Iron, Ferritin and Transferrin Levels
Time Frame
16 Weeks
Title
Time to Global Response
Time Frame
Up to 4 months
Title
Percentage of Participants with a Positive Response
Time Frame
Weeks 4 and 8
Title
Quality of Life in Relation to Grade of Anemia
Time Frame
Up to 4 months
Title
Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument
Time Frame
Up to 4 months
Title
Tolerability - Incidence of Adverse Events
Time Frame
Up to 16 Weeks of treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult participants with a diagnosis of non-Hodgkin's lymphoma, chronic lymphocytic leukemia or multiple myeloma
Anemia at Screening Visit
Exclusion Criteria:
Transfusion of red blood cells within 2 months of study drug
Treatment-resistant hypertension
Acute or chronic bleeding (requiring therapy) within 3 months of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Caracas
ZIP/Postal Code
1040
Country
Venezuela
City
Caracas
ZIP/Postal Code
2122
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B
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