Status:
COMPLETED
Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
Lead Sponsor:
Amgen
Conditions:
MDS
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) i...
Eligibility Criteria
Inclusion
- Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles
Exclusion
- Prior exposure to \>3 cycles hypomethylating agents
- Prior history of leukemia or aplastic anemia
- Prior history of bone marrow transplantation
- Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization
- Active or uncontrolled infections
- Unstable angina, congestive heart failure \[NYHA (New York Heart Association) \> class II\], uncontrolled hypertension \[diastolic \> 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
- History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
- History of venous thrombosis that currently requires anti-coagulation therapy
- Received IL-11 within 4 weeks of screening
- Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication
- Have previously received any other thrombopoietic growth factor
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00321711
Start Date
October 1 2006
End Date
October 19 2009
Last Update
October 17 2018
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