A Study to Assess the Hematopoyetic Response of Anemic Patients With Hematologic Malignancies Treated With Erythropoietin B

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Epoetin Beta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Beta - 30000 IU<br>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. | Drug: Epoetin Beta<br>* 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.<br>* Other names: Recormon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin levels at 16 weeks |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Iron, Ferritin and Transferrin Levels |  | 16 Weeks | 
| Time to Global Response |  | Up to 4 months | 
| Percentage of Participants with a Positive Response |  | Weeks 4 and 8 | 
| Quality of Life in Relation to Grade of Anemia |  | Up to 4 months | 
| Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument |  | Up to 4 months | 
| Tolerability - Incidence of Adverse Events |  | Up to 16 Weeks of treatment period |