An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MOS)
- Conditions
- ow or Intermediate Risk Myelodysplastic Syndrome (MDS)MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome
- Registration Number
- EUCTR2007-001516-24-FR
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Disease related:
• Completion of a romiplostim study including the End of Study visit for the treatment of thrombocytopenia in subjects with IPSS low to int-1 risk MDS (e.g. 20050159 or 20060198)
Demographic:
• Eastern Cooperative Oncology ( ECOG) performance status of 0-2
Laboratory:
• Adequate Liver Function, as evidenced by a serum bilirubin = 2 times the laboratory normal range and unconjugated bilirubin =90% of total bilirubin (except for patients with a confirmed diagnosis of Gilbert’s Disease), ALT = 3 times the laboratory normal range, and AST = 3 times the laboratory normal range
• A serum creatinine concentration = 2 mg/dl
• Platelet count = 50 x 109/ L
General:
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Disease Related:
• Evidence of progression/transformation of disease (i.e. increase in bone marrow myeloblasts by = 5% or worsening cytogenetics since screening for parent study)
• Prior history of leukemia or aplastic anemia
• Prior history of bone marrow or stem cell transplantation
• 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
• 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 that currently requires anti-coagulation therapy
Medications:
• Received IL-11 within 4 weeks of screening
• Receipt of hypomethylating agents or immunomodulating agents, high-dose chemotherapy targeted at MDS, or histone deacetylase inhibitors
• Have previously received any other thrombopoietic growth factor
• Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
General:
• Subject currently is enrolled in or has not yet completed at least 4 weeks since ending investigational device or drug study(s) (other than AMG 531), or subject is receiving other investigational agent(s)
• Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
• Subject is not using adequate contraceptive precautions
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with IPSS low or intermediate-1 risk MDS.;Secondary Objective: The secondary objective is to evaluate the effectiveness of romiplostim with respect to platelet response, transfusion, and bleeding events in the treatment of thrombocytopenic subjects with IPSS low or intermediate-1 risk MDS.;Primary end point(s): The primary endpoint is the incidence of AEs, including clinically significant changes in laboratory values and incidence of antibody formation.
- Secondary Outcome Measures
Name Time Method