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

Amgen

Status

Completed

Conditions

Hematology

Thrombocytopenia

MDS

Myelodysplastic Syndromes

Treatments

Drug: Romiplostim (formerly AMG 531)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00472290

20060197

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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