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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02608060
• Other study ID #: ML18055
• Status: Terminated
• Phase: Phase 4
• First received: November 16, 2015
• Last updated: November 1, 2016
• Start date: September 2006
• Est. completion date: October 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Institutional Ethical Committe and Health Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Epoetin 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin levels at 16 weeks		16 Weeks	No
Secondary	Serum Iron, Ferritin and Transferrin Levels		16 Weeks	No
Secondary	Time to Global Response		Up to 4 months	No
Secondary	Percentage of Participants with a Positive Response		Weeks 4 and 8	No
Secondary	Quality of Life in Relation to Grade of Anemia		Up to 4 months	No
Secondary	Quality of Life According to the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Instrument		Up to 4 months	No
Secondary	Tolerability - Incidence of Adverse Events		Up to 16 Weeks of treatment period	No