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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

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ClinicalTrials.gov Identifier: NCT00695396
Recruitment Status : Terminated (The study was stopped due to low subject enrollment. No safety issue or other concern factored into this decision.)
First Posted : June 11, 2008
Results First Posted : March 17, 2011
Last Update Posted : October 5, 2012
Sponsor:
Collaborator:
Centocor Ortho Biotech Services, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Anemia Drug: Placebo Drug: Epoetin alfa Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010


Arm Intervention/treatment
Experimental: 001
Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks
Drug: Epoetin alfa
40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks
Experimental: 002
Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Drug: Epoetin alfa
80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Placebo Comparator: 003
Placebo Matching volume 1 mL for 48 weeks
Drug: Placebo
Matching volume 1 mL for 48 weeks
Placebo Comparator: 004
Placebo Matching volume 2 mLfor 48 weeks
Drug: Placebo
Matching volume 2 mLfor 48 weeks



Primary Outcome Measures :
  1. Red Blood Cell (RBC) Transfusion [ Time Frame: Approximately 48 weeks ]
    Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)


Secondary Outcome Measures :
  1. RBC Transfusion From Day 29 Through the End of Study [ Time Frame: Day 29 through the end of study (approximately 48 weeks) ]
    incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).

  2. Transfusion Dependent [ Time Frame: Approximately 48 weeks ]
    Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695396


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Centocor Ortho Biotech Services, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Responsible Party: CDTL PROCURIT/EPREX, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00695396     History of Changes
Other Study ID Numbers: CR013651
EPOANE3018
First Posted: June 11, 2008    Key Record Dates
Results First Posted: March 17, 2011
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
MDS
Myelodysplastic syndromes
Anemia
Epoetin alfa
EPO

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Hematinics