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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndromes, Anemia

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Trial Information

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.


Inclusion Criteria:



- Diagnosis of MDS according to protocol-specified criteria via bone marrow studies
performed within 12 weeks before randomization

Exclusion Criteria:

- No prior or concurrent treatment with epoetin alfa or any other approved or
experimental erythropoietin stimulating agents (ESAs) within the previous 12 months
before randomization

- No prior use of approved or experimental agents for the treatment of MDS or recent
treatment with granulocyte colony stimulating factor (G-CSF) or granulocyte
macrophage colony stimulating factor (GM-CSF) for the treatment of neutropenia

- Patients must not have secondary MDS or anemia caused by factors other than MDS
(including iron deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic
renal failure, or gastrointestinal bleeding)

- No history (within 12 months) of deep venous thrombosis

- or history (within 6 months) of stroke, acute coronary syndrome or other arterial
thrombosis

- Not currently receiving therapeutic anticoagulants or have uncontrolled hypertension

- No uncontrolled disease or dysfunction deemed clinically significant by the
Investigator not attributable to MDS

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Red Blood Cell (RBC) Transfusion

Outcome Description:

Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)

Outcome Time Frame:

Approximately 48 weeks

Safety Issue:

No

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

CR013651

NCT ID:

NCT00695396

Start Date:

June 2008

Completion Date:

January 2010

Related Keywords:

  • Myelodysplastic Syndromes
  • Anemia
  • MDS
  • Myelodysplastic syndromes
  • Anemia
  • Epoetin alfa
  • EPO
  • Anemia
  • Myelodysplastic Syndromes
  • Preleukemia

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