At a glance
ClinicalIndex Comparison Record- ✓Completed a prior romiplostim study for thrombocytopenia in MDS
- ✓ECOG performance status 0–2
- ✓Platelet count ≤50×10⁹/L since final dose in parent study
- ✕AML diagnosis or blast count ≥10% in peripheral blood or bone marrow
- ✕Prior history of leukemia
- ✕Prior bone marrow or stem cell transplantation
- ✕Prior malignancy (except in situ cervical, controlled prostate, or skin basal cell) without ≥3 years disease-free period
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
In Brief
A clinical study evaluating Romiplostim (formerly AMG 531) for Hematology and 3 related conditions. Completed, enrolled 72 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.