A Safety and Efficacy Study to Evaluate AMG 531 Treatment in Subject With Myelodysplastic Syndrome Receiving Revlimid
Condition: Myelodysplastic Syndromes; Thrombocytopenia
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Thrombocytopenia; Syndrome
Intervention: AMG 531; Placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Revlimid; Lenalidomide; Low Platelet Count; Low Risk Myelodysplastic Syndrome; Intermediate 1 Myelodysplastic Syndrome; MDS; Myelodysplastic Syndrome

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO)
             classification

          -  Low or Intermediate-1 risk category MDS using the IPSS

          -  Planned to receive lenalidomide 10 mg capsule by mouth daily for all 28 days of each
             cycle for at least 4 cycles

          -  Eastern Cooperative Oncology (ECOG) performance status of 0-2

          -  Subjects must be at least 18 years of age or older

        Exclusion Criteria:

          -  Prior exposure to >3 cycles of lenalidomide

          -  Exposure to lenalidomide within the last 30 days

          -  Prior history of leukemia or aplastic anemia

          -  Prior history of stem cell transplantation

          -  Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin)
             unless treated with curative intent and without evidence of disease for 3 years before
             randomization

          -  Active or uncontrolled infections

          -  Unstable angina, congestive heart failure [NYHA > class II], uncontrolled hypertension
             [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year)
             myocardial infarction

          -  History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past
             year

          -  History of venous thrombosis in the past year

          -  Received IL-11 within 4 weeks of screening

          -  Less than 4 weeks since receipt of any investigational drug or device

          -  Have previously received any other thrombopoietic growth factor

          -  Pregnant or breast feeding

          -  Subjects of reproductive potential who are not using adequate contraceptive
             precautions, in the judgment of the investigator

          -  Known hypersensitivity to any recombinant E coli-derived product