A Randomized, Double Blind, Placebo Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syndromes at Risk For Transfusion
This is a randomized (patients are assigned by chance to a treatment group), double-blind
(neither the patient or the physician know which treatment is being received by the
patient), placebo-controlled, multicenter study of epoetin alfa in anemic patients who are
diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria.
Patients meeting entry criteria for the study will be randomly assigned to receive epoetin
alfa 40,000 IU or 80,000 IU or a matching volume of placebo administered by subcutaneous
(under the skin) injection once every week. Doses of study drug will be withheld, decreased,
or increased on the basis of weekly hemoglobin concentrations monitored in patients and
predefined dose adjustment guidelines. An Independent Data Monitoring Committee (IDMC) will
periodically review study data and for the assessment of disease progression, an independent
central reviewer will review bone marrow specimens and peripheral blood counts. Safety will
be monitored throughout the study at predetermined intervals and as clinically indicated by
physical examination, laboratory tests and evaluation of adverse events. Patients in the
Treatment Phase will be randomly assigned to receive once weekly epoetin alfa subcutaneously
(SC) at a dose of 40,000 IU (1 mL) or 80,000 IU (2ML) or matching volume of placebo (1 mL or
2 mL) once every week for 48 weeks. Patients may continue to receive double-blinded
treatment after 48-weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Red Blood Cell (RBC) Transfusion
Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)
Approximately 48 weeks
No
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration
CR013651
NCT00695396
June 2008
January 2010
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