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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564094

Enrollment

Registered

2015-09-30

Start date

2005-02-28

Completion date

2006-06-30

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 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.

Interventions

DRUGEpoetin beta

Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.

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

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of adverse events (AEs)	Up to approximately 6 months

Countries

Bulgaria

Outcome results

None listed

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