A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion

NCT ID: NCT00695396

Last Updated: 2012-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a group of disorders characterized by progressive bone marrow failure and an increased risk of development of leukemia.

Detailed Description

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.

Conditions

Myelodysplastic Syndromes; Anemia

Keywords

MDS; Myelodysplastic syndromes; Anemia; Epoetin alfa; EPO

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

001

Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks

Group Type: EXPERIMENTAL

Epoetin alfa

Intervention Type: DRUG

40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks

002

Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks

Group Type: EXPERIMENTAL

Epoetin alfa

Intervention Type: DRUG

80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks

003

Placebo Matching volume 1 mL for 48 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching volume 1 mL for 48 weeks

004

Placebo Matching volume 2 mLfor 48 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching volume 2 mLfor 48 weeks

Interventions

Placebo

Matching volume 2 mLfor 48 weeks

Intervention Type: DRUG

Epoetin alfa

40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks

Intervention Type: DRUG

Placebo

Matching volume 1 mL for 48 weeks

Intervention Type: DRUG

Epoetin alfa

80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

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

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Countries

Brazil; Canada; Czechia; Russia; United States

Other Identifiers

EPOANE3018

Identifier Type: -

Identifier Source: secondary_id

CR013651

Identifier Type: -

Identifier Source: org_study_id