Conditions: MDS Myelodysplastic Syndromes Thrombocytopenia
Keywords: MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 69
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.

Detailed description:

Arms:
arm 1: 500 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 2: 750 mcg AMG 531 weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles arm 3: 750 mcg AMG 531 weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 4: Placebo weekly via subcutaneous injection + 75 mg/m2 azacitidine for 4 cycles arm 5: Placebo weekly via subcutaneous injection + 20 mg/m2 decitabine for 4 cycles

Interventions: intervention 1: Placebo intervention 2: AMG 531 (Romiplostim) intervention 3: Azacitidine intervention 4: Decitabine
Intervention descriptions: intervention 1: Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period. intervention 2: AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period, depending on randomization. intervention 3: hypomethylating agent intervention 4: hypomethylating agent

Protocol document: