Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) MedDRA version: 9.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Product Name: Romiplostim
Product Code: AMG 531
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: AMG 531
Concentration unit: µg microgram(s)
Concentration type: equal
Conce
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease related: • Subject completed a romiplostim study for the treatment of thrombocytopenia in subjects with MDS Demographic: • Eastern Cooperative Oncology ( ECOG) performance status of 0-2 Laboratory: • Subject had a platelet count of = 50 x 109/L since the final dose of investigational product in the parent study General: • Subject or his/her legally acceptable representative provided written informed before any study-specific procedures were initiated 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
Exclusion criteria
Exclusion criteria: Disease Related: • Subject has been diagnosed with AML or has a blast count = 20% by peripheral blood or bone marrow biopsy • Subject has prior history of leukemia • 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 • Subject previously received a thrombopoietic growth factor (other than romiplostim) • 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 four weeks since ending investigational device or drug study(s) (other than romiplostim), 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 his/her ability to give written informed consent (and does not have a legally acceptable representative; see Section 12.1) or is unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to provide long-term safety data for the use of romiplostim in thrombocytopenic subjects with myelodysplastic syndromes (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 MDS.;Primary end point(s): The primary endpoint is the incidence of all adverse events, including clinically significant changes in laboratory values and incidence of antibody formation. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden
Outcome results
None listed