A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-06

Study Completion Date

2019-04-09

Brief Summary

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This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult participants associated with low/intermediate-1-risk MDS. After screening, eligible participants will be treated with epoetin beta as recommended in the approved label and international guidelines for the use of epoetin in MDS participants and the dosage will be adjusted on the basis of erythroid response.

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Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epoetin Beta

Participants will receive epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Response will be firstly evaluated at Week 4 and the subsequent dose will be based on the response: if hemoglobin level reaches greater than or equal to (\>/=)12 grams per deciliter (g/dL) at any time, epoetin beta will be discontinued until hemoglobin levels are less than or equal to (\</=) 10 g/dL; if the hemoglobin level increases less than (\<) 1 g/dL from screening level and hemoglobin level ˂12 g/dL, a 60,000 IU per week epoetin beta will be administered SC until Week 12; if the hemoglobin level increases \>/=1 g/dL from screening level and hemoglobin level ˂12 g/dL, a 30,000 IU per week epoetin beta will be continued until Week 12.

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

Epoetin beta 30,000 or 60,000 IU per week SC injection

Interventions

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Epoetin beta

Epoetin beta 30,000 or 60,000 IU per week SC injection

Intervention Type DRUG

Other Intervention Names

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Recormon

Eligibility Criteria

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Inclusion Criteria

* Adult participants with low or intermediate-1 risk MDS
* No previous treatment with hematopoietic growth factors within 3 months prior to screening
* Symptomatic anemia (hemoglobin \<10 g/dL) as determined by investigator
* Serum erythropoietin \<500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment
* Require no red blood cell transfusion or dependent on \<4 units within 8 weeks prior to screening
* Clinically stable for at least 1 month prior to entry into the study
* For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception

Exclusion Criteria

* Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment
* Poorly controlled hypertension as assessed by the investigator
* History of Acute Myeloid Leukemia (AML) or high risk for AML
* Administration of another investigational drug within 1 month before screening or planned during the study period
* Previously documented evidence of Pure Red Cell Aplasia (PRCA)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No