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

Hoffmann-La Roche54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

Epoetin betaDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Plovdiv, Bulgaria

Unnamed facility

Plovdiv, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Outcomes

Primary Outcomes

Response rate according to hemoglobin level

Time frame: At Week 4

Transfusion requirement rate

Time frame: From Weeks 5 to 12

Predictive value of reticulocyte increase

Time frame: At Week 2

Secondary Outcomes

Incidence of adverse events (AEs)

Time frame: Up to approximately 6 months

Data from ClinicalTrials.gov

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