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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02608060

Enrollment

Registered

2015-11-18

Start date

2006-09-30

Completion date

2007-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

DRUGEpoetin Beta

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hemoglobin levels at 16 weeks	16 Weeks

Secondary

Measure	Time frame
Time to Global Response	Up to 4 months
Percentage of Participants with a Positive Response	Weeks 4 and 8
Serum Iron, Ferritin and Transferrin Levels	16 Weeks
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
Quality of Life in Relation to Grade of Anemia	Up to 4 months

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026