Status:
COMPLETED
A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
Lead Sponsor:
Amgen
Conditions:
Myelodysplastic Syndromes
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodyspl...
Eligibility Criteria
Inclusion
- Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification
- Low or Intermediate-1 risk category MDS using the IPSS
- Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each cycle for at least 4 cycles
- Eastern Cooperative Oncology (ECOG) performance status of 0-2
- Subjects must be at least 18 years of age or older
Exclusion
- Prior exposure to \>3 cycles of lenalidomide
- Exposure to lenalidomide within the last 30 days
- Prior history of leukemia or aplastic anemia
- Prior history of stem cell 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 years before randomization
- Active or uncontrolled infections
- Unstable angina, congestive heart failure \[NYHA \> class II\], 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 in the past year
- Received IL-11 within 4 weeks of screening
- Less than 4 weeks since receipt of any investigational drug or device
- Have previously received any other thrombopoietic growth factor
- Pregnant or breast feeding
- Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
- Known hypersensitivity to any recombinant E coli-derived product
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00418665
Start Date
December 1 2006
End Date
October 1 2010
Last Update
January 24 2011
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