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Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
Not Recruiting
Trial ID: NCT00321711
Purpose
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) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS)
receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the
appropriate dose and schedule, will result in reduction in the incidence of clinically
significant thrombocytopenic events in low or intermediate risk MDS subjects receiving
hypomethylating agents.
Official Title
A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents
Stanford Investigator(s)
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
Inclusion Criteria: - 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
Criteria:
- 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
Intervention(s):
drug: Placebo
biological: AMG 531 (Romiplostim)
drug: Azacitidine
drug: Decitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mai Tran
6507238594