The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.
Study Type
INTERVENTIONAL
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
39
Planned Cohorts: 1. 100 mcg, 2. 300 mcg, 3. 700 mcg, 4. 1000 mcg; Optional Cohorts: 5. cohort expansion, 6. schedule change, 7. new dose
Change in Platelet Nadir
Change in platelet nadir from the previous qualifying cycle to the first treatment cycle.
Time frame: 32 weeks
Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia
Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L, and \<25 x 10\^9/L)
Time frame: 32 weeks
Duration of Grade 3 or 4 Thrombocytopenia
Duration of grade 3 and/or 4 thrombocytopenia (\<50 x 10\^9/L and \<25 x 10\^9/L, respectively)
Time frame: 32 weeks
Percentage of Subjects That Received Platelet Transfusions
Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle
Time frame: 32 weeks
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