NCT00463385

A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Participants received study treatment in the Double Blind Treatment Phase for up to 12 cycles (336 days; 12 cycles of 28 days each). Participants who completed the Double-Blind Treatment Phase were unblinded and, if receiving pomalidomide and determined to have a complete remission (CR), partial remission (PR) or clinical improvement (CI) using the International Working Group (IWG) Response Criteria in the study protocol, could have continued on their current dose of pomalidomide until disease progression. Participants receiving placebo were discontinued from the study.

Conditions

• Myelofibrosis With Myeloid Metaplasia
• Myeloid Metaplasia
• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Pomalidomide
DRUG	Prednisone	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.
DRUG	Placebo to pomalidomide	Matching pomalidomide placebo tablets
DRUG	Placebo to prednisone	Matching prednisone placebo tablets

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-05-01
• Completion: 2013-12-31
• First posted: 2007-04-20
• Last updated: 2019-11-20
• Results posted: 2013-10-28

Locations

11 sites across 5 countries: United States, Austria, Italy, Spain, United Kingdom