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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Epoetin beta 30,000 or 60,000 IU per week SC injection
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand
Rajavithi Hospital; Medicine
Bangkok, Thailand
Ramathibodi Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand
Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria
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.
Time frame: Week 12
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
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.
Time frame: Week 12
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
Neutrophil response according to IWG 2006 criteria was defined as at least 100% increase and an absolute increase of \>0.5x10\^9/L.
Time frame: Week 12
Percentage of Participants With Adverse Events
Time frame: From signing of informed consent up to 4 weeks after last dose (up to 18 weeks)
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Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Chiang Mai, Thailand
Khonkean Regional Hospital; Medicine
Khon Kaen, Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, Thailand
Thammasart Chalermprakiert Hospital, Thammasart Uni; Hematology
Pathum Thani, Thailand
Naresaun University hospital
Phitsanulok, Thailand
Sapprasitthiprasong Hospital
Ubon Ratchathani, Thailand