Conditions: Myelodysplastic Syndromes Thrombocytopenia
Keywords: Revlimid Lenalidomide Low Platelet Count Low Risk Myelodysplastic Syndrome Intermediate 1 Myelodysplastic Syndrome MDS Myelodysplastic Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
This is a dose and schedule finding study of AMG 531 designed to assess the activity of AMG 531 to reduce the rate of clinically significant bleeding and blood transfusions in subjects with myelodysplastic syndrome (MDS) receiving lenalidomide. Subjects with MDS that are planned to receive at least four cycles of lenalidomide for treatment of their disease are appropriate to screen for this study.

All subjects meeting the eligibility criteria will receive lenalidomide 10 mg capsule by mouth daily every day of each 28-day cycle. Subjects will receive AMG 531 or placebo once a week by subcutaneous injection for 16 weeks.

Detailed description:

Arms:
arm 1: 750 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 2: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B) arm 3: Placebo weekly via subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 4: 500 μg AMG 531 weekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part A) arm 5: 750 μg AMG 531 biweekly by subcutaneous injection + lenalidomide (10 mg orally per day) for 16 weeks (Part B)

Interventions: intervention 1: AMG 531 intervention 2: Placebo
Intervention descriptions: intervention 1: AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg. intervention 2: Subjects in the control group will receive placebo via subcutaneous injection.

Protocol document: