NCT00321711 - Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 1, 2006

Primary Completion Date

October 19, 2009

Study Completion Date

October 19, 2009

Conditions

MDSMyelodysplastic SyndromesThrombocytopenia

Interventions

DRUG

Placebo

Subjects in the control group will receive a placebo subcutaneous injection on a weekly basis during the 4 cycle treatment period.

BIOLOGICAL

AMG 531 (Romiplostim)

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.

DRUG

Azacitidine

hypomethylating agent

DRUG

Decitabine

hypomethylating agent