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Study Complete
Sponsor ID
20060197

Evaluating the Safety of Long Term Dosing of Romiplostim (formerly AMG 531) in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)

Sponsor ID
20060197
Clinicaltrials.gov ID
NCT00472290
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.

Additional Study Details

Phase
N/A
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
72
Additional Study Details

Protocol Summary

Primary Outcome Measures

To provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with MDS

Timeframe: Duration of the treatment

Secondary Outcome Measures

To evaluate the effectiveness of romiplostim with respect to platelet response, transfusion, and bleeding events in the treatment of thrombocytopenic subjects with MDS

Timeframe: Duration of the treatment

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Blood Cancer (Other)
    • Show more
  • Myelodysplastic Syndrome
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Apr 2007 - Jul 2011
    Inclusion and Exclusion Criteria
    Inclusion Criteria • Subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with MDS • Subject has an Eastern Cooperative Oncology (ECOG) performance status of 0 to 2 • Subject had a platelet count ≤ 50 x 10^9/L since the final dose of investigational product in the parent study • Subject or his/her legally acceptable representative provided written informed consent before any study-specific procedures were initiated Exclusion Criteria • Subject has been diagnosed with AML or has a blast count ≥ 10% by peripheral blood or bone marrow biopsy • Subject has a prior history of leukemia • Subject has a prior history of bone marrow or stem cell transplantation • Subject has a prior malignancy (other than in situ cervical cancer, controlled prostate cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years before randomization • Subject has active or uncontrolled infections • Subject has unstable angina, congestive heart failure [New York Heart Association (NYHA) > class II], uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction • Subject has a history of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year • Subject has a history of venous thrombosis that currently requires anti-coagulation therapy • Subject received interleukin (IL)-11 within 4 weeks of screening • Subject previously received a thrombopoietic growth factor (other than romiplostim) • Subject has a known hypersensitivity to any recombinant E coli-derived product (eg, Infergen®, Neupogen®, Somatropin, Actimmune) • Subject is currently enrolled in investigational device or drug study(ies), has not yet completed at least 4 weeks since ending investigational device or drug study(ies) (other than parent romiplostim study), or subject is receiving other investigational agent(s)/device(s) • Subject is of child-bearing potential and is evidently pregnant (eg, positive human chorionic gonadotropin [HCG] test) or is breast feeding • Subject is not using adequate contraceptive precautions • Subject has any kind of disorder that compromises his/her ability to give written informed consent (and does not have a legally acceptable representative) or is unable to comply with study procedures