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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
39
AMG 531 will be administered by subcutaneous injection at a dose of 500 or 750 μg.
Subjects in the control group will receive placebo via subcutaneous injection.
Occurrence of a Clinically Significant Thrombocytopenic Event
Occurrence of one or more clinically significant thrombocytopenic events, defined as either Common Terminology Criteria for Adverse Events (CTCAE) v. 3 grade 3 or 4 thrombocytopenia starting from week 3 of cycle 1 or receipt of platelet transfusions starting from week 1 of cycle 1 and continuing through the end of treatment visit.
Time frame: Treatment period through interim follow-up visit (up to 16 weeks)
Lenalidomide Dose Reduction and Delay Due to Thrombocytopenia
Occurrence of lenalidomide dose reduction and delay due to thrombocytopenia
Time frame: Treatment period (up to 16 weeks)
Achieving an Overall Response (Complete Response (CR) or Partial Response (PR)) Determined by the Investigator Based on Modified International Working Group 2006 Response Criteria Guidelines
CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10\^9/L, neutrophils ≥ 1x10\^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.
Time frame: Treatment period and post-treatment follow-up (up to 21 weeks)
Platelet Transfusion
Occurrence of one or more platelet transfusions during the treatment period
Time frame: Treatment period (up to 16 weeks)
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