At a glance
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A Phase 2, Prospective, Randomized, Multicenter, Double-blind, Active-control, Parallel-group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 (Pomalidomide) Either as Single-agent or in Combination With Prednisone to Study Further in Subjects With Myelofibrosis With Myeloid Metaplasia
In Brief
A Phase 2 clinical trial evaluating Pomalidomide, Prednisone, and 2 other interventions for Myelofibrosis With Myeloid Metaplasia and 2 related conditions. Completed, enrolled 88 participants across 11 sites in 5 countries.
Detailed Summary
The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with myeloid metaplasia (MMM).
Study Details
Timeline
Interventions
Participants will take oral prednisone in the evening for 3 cycles of 28 days each (up to 84 days). The dose will be as follows: 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day.
Matching pomalidomide placebo tablets
Matching prednisone placebo tablets