Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
NCT ID: NCT00472290
Last Updated: 2017-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2007-04-01
2011-12-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open Label Romiplostim (formerly AMG 531)
Romiplostim (formerly AMG 531)
Subjects will begin the study at an initial dose of 750 µg.
Except for:
* Subject whose doses were escalated to doses higher than 750 µg AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.
* Subjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count.
Interventions
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Romiplostim (formerly AMG 531)
Subjects will begin the study at an initial dose of 750 µg.
Except for:
* Subject whose doses were escalated to doses higher than 750 µg AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.
* Subjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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Fenaux P, Muus P, Kantarjian H, Lyons RM, Larson RA, Sekeres MA, Becker PS, Orejudos A, Franklin J. Romiplostim monotherapy in thrombocytopenic patients with myelodysplastic syndromes: long-term safety and efficacy. Br J Haematol. 2017 Sep;178(6):906-913. doi: 10.1111/bjh.14792. Epub 2017 Jun 14.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20060197
Identifier Type: -
Identifier Source: org_study_id