A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) - 20060198

Conditions: low or intermediate-1 risk MDS
MedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

Registration Number: EUCTR2007-007258-75-IT

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

Diagnosis of MDS using the WHO classification
Per MDS IPSS, low or intermediate-1 risk MDS
The mean of the two platelet counts taken within 4 weeks prior to randomization must be:
o ≤ 20 x 109/L, with no individual count >30 x 109/L, with or without a history of bleeding, OR
o ≤ 50 x 109/L, with no individual count >60 x 109/L with a history of bleeding.
A standard of care platelet count taken prior to Informed Consent may be used as 1 of the 2 counts taken within 4 weeks prior to randomization
Subjects must be ≥18 and ≤ 90 years of age at the time of informed consent. Subjects between 85 and 90 years of age must have been diagnosed with MDS ≤ 5 years from study start.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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 (≤176.8 μmol/L)
Bone marrow biopsy and aspirate with cytogenetics within 3 months of starting first dose of investigational product
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Have ever received any disease-modifying treatment for MDS
Previously diagnosed with intermediate-2 or high risk MDS using the IPSS
Prior history of leukemia, aplastic anemia, or other non-MDS related bone marrow stem cell disorder
Prior history of hematopoietic stem cell transplantation
Persistent peripheral blood monocytosis (≥ 3 months with an absolute monocyte count >1,000/μL)
Prior malignancy (other than in situ cervical cancer, non-melanoma skin cancer, or in situ carcinoma) 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) within the past year
History of venous thrombosis that currently requires anti-coagulation therapy
Received IL-11 within 4 weeks of the first dose of investigational product
Have previously received any thrombopoietic growth factor
Receipt of G-CSF, peg-G-CSF, or GM-CSF within 4 weeks of the first dose of investigational product
Planned receipt of peg-G-CSF or GM-CSF after the first dose of investigational product
Pregnant or breast feeding
Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator. Amgen recommends double barrier contraception is used for all applicable patients enrolled on this study. A double barrier method is defined as two methods of contraception, for example 2 actual barrier methods, or one actual barrier method and one hormonal method.
Known hypersensitivity to any recombinant E coli-derived product
Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s)