To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of lymphomas measured by the ability to administer on-time, full-dose chemotherapy.
This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of lymphomas, defined by 2 platelet counts \< 30 x 10\^9/L at least 7 days apart. The study will consist of a screening period of up to 4 weeks, a 16-week treatment period, an end-of-treatment (EOT) visit, and long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
This trial is designed to study romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lymphoma.
Placebo Comparator
Chemotherapy dose delay or reduction
Either a chemotherapy dose delay by ≥ 4 days or chemotherapy dose reduction by ≥ 15% due to thrombocytopenia as measured in any 2 planned cycles of chemotherapy during the treatment period.
Time frame: 17 weeks
Platelet recovery
The time to first platelet recovery, defined by platelet count ≥ 50 x 10\^9/L in the absence of platelet transfusions during the preceding 7 days
Time frame: 7 days post transfusion through platelet recovery
Platelet count
Achieving a platelet count ≥ 50 x 10\^9/L, assessed 7 days after the third dose of investigational product and in the absence of platelet transfusions during the preceding 7 days
Time frame: 7 days after 3rd dose of IP with no transfusions in preceding 7 days
Depth of the platelet count
The depth of the platelet count nadir for chemotherapy cycles administered after the third dose of investigational product through the end of the treatment period
Time frame: 3rd dose of IP through End of treatment, up to 43 months
Subject Incidence of Platelet Transfusion
Incidence of platelet transfusions during the treatment period
Time frame: Through treatment period, up to 17 weeks
Bleeding events
the duration-adjusted event rate of ≥ grade 2 bleeding events, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), during the treatment period
Time frame: Through treatment period, up to 17 weeks
Adverse Events, Serious Adverse Events, clinically significant lab value changes
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adverse events, including treatment-emergent adverse events, serious adverse events and clinically significant changes in laboratory values
Time frame: Through treatment period, up to 17 weeks
Antibody Formation
anti-romiplostim antibodies and antibodies to TPO
Time frame: throughout treatment period, up to 17 weeks
Vital Status
vital status
Time frame: treatment period through end of study, up to 43 months
Changes in health
myelodysplastic syndromes and secondary malignancies
Time frame: treatment period through end of study, up to 43 months