Symptoms and General Pathology

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Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Anti-Inflammatory Agents

Antirheumatic Agents

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Hematinics

Chrysarobin

Epoetin Alfa

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.

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

Epoetin beta

Clinical Trials

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.

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

A Prospective Open-Label Study of the Effectiveness of Epoetin Beta for Treating Anemic Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome (MDS)

Erythroid response at Week 12 according to IWG 2006 criteria was defined as a hemoglobin (Hb) increase of \>/= 1.5 grams/deciliter (g/dL), and a reduction of units of red blood cell (RBC) transfusions by at least 4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only RBC transfusions given for an Hb of \</= 9.0 g/dL pre-treatment were counted in the RBC transfusion response evaluation.

Platelet response according to IWG 2006 criteria was defined as an absolute increase of \>/= 30x10\^9/L for participants starting with \>20x10\^9/L platelets.

Neutrophil response according to IWG 2006 criteria was defined as at least 100% increase and an absolute increase of \>0.5x10\^9/L.

Hoffmann-La Roche

Participants received epoetin beta at an initial dose of 30,000 International Units (IU) per week administered subcutaneously (SC). Initial response was evaluated at Week 4 and the subsequent dose was based on response: for hemoglobin levels \>/= 12 grams per deciliter (g/dL), epoetin beta was discontinued until levels were \</= 10 g/dL; for hemoglobin levels \<12 g/dL and that increased less than 1 g/dL, 60,000 IU of epoetin beta were administered until Week 12; and for hemoglobin levels \<12 g/dL and that increased \>/= 1 g/dL, 30,000 IU of epoetin beta were administered until Week 12.

Epoetin Beta

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

1 participant withdrew at the baseline visit prior to study treatment and was not included in baseline, safety, and intent-to-treat (ITT) analyses.

Data for the secondary efficacy endpoints (% of participants with platelet response and % of participants with neutrophil response) is not conclusive given the small number of participants meeting the evaluation criteria for each endpoint.

Medical Communications

Efficacy analysis was performed on the intent-to-treat (ITT) population, defined as all enrolled participants who received at least one dose of study medication.

Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria

Percentage of Participants With Platelet Response (in Participants With Pre-Treatment Platelets <100*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria

Percentage of Participants With Neutrophil Response (in Participants With Pre-Treatment Neutrophil <1.0*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria

The safety population included all participants that received at least one dose of study medication.

Spots Global Cancer Trial Database for A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

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