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
Primary Purpose
Myelodysplastic Syndromes, Anemia
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Epoetin alfa
Placebo
Epoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, Myelodysplastic syndromes, Anemia, Epoetin alfa, EPO
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
001
002
003
004
Arm Description
Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks
Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Placebo Matching volume 1 mL for 48 weeks
Placebo Matching volume 2 mLfor 48 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
RBC Transfusion From Day 29 Through the End of Study
incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).
Transfusion Dependent
Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.
Full Information
NCT ID
NCT00695396
First Posted
June 5, 2008
Last Updated
October 2, 2012
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Centocor Ortho Biotech Services, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00695396
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to low subject enrollment. No safety issue or other concern factored into this decision.
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Centocor Ortho Biotech Services, L.L.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Anemia
Keywords
MDS, Myelodysplastic syndromes, Anemia, Epoetin alfa, EPO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
Epoetin alfa 40 000 IU subcutaneously once every week (1 mL dose) for 48 weeks
Arm Title
002
Arm Type
Experimental
Arm Description
Epoetin alfa 80 000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Arm Title
003
Arm Type
Placebo Comparator
Arm Description
Placebo Matching volume 1 mL for 48 weeks
Arm Title
004
Arm Type
Placebo Comparator
Arm Description
Placebo Matching volume 2 mLfor 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching volume 2 mLfor 48 weeks
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
40,000 IU subcutaneously once every week (1 mL dose) for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching volume 1 mL for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
80,000 IU subcutaneously once every week (2 mL dose) for 48 weeks
Primary Outcome Measure Information:
Title
Red Blood Cell (RBC) Transfusion
Description
Incidence of participants who received at least 1 Red Blood Cell (RBC) transfusion during the study (from randomization through the end of study)
Time Frame
Approximately 48 weeks
Secondary Outcome Measure Information:
Title
RBC Transfusion From Day 29 Through the End of Study
Description
incidence of participants who received at least 1 RBC transfusion from Day 29 through the end of study (approximately 48 weeks).
Time Frame
Day 29 through the end of study (approximately 48 weeks)
Title
Transfusion Dependent
Description
Participants who were transfusion-dependent were those who received 4 or more RBC units during a consecutive 8-week period.
Time Frame
Approximately 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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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