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Completed

NCT Number: NCT02145026

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

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Epoetin beta

Drug

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

Other names: Recormon

Primary outcomes

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

    Time frame: Week 12

    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.

Secondary outcomes

  1. 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

    Time frame: Week 12

    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.

  2. 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

    Time frame: Week 12

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

  3. Percentage of Participants With Adverse Events

    Time frame: From signing of informed consent up to 4 weeks after last dose (up to 18 weeks)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 22, 2014
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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