NCT00321711

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

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim (AMG 531) Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MDS
• Myelodysplastic Syndromes
• Thrombocytopenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-10-19
• Completion: 2009-10-19
• First posted: 2006-05-04
• Last updated: 2018-10-17
• Results posted: 2011-04-05