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A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia

NCT00463385 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-11-20

Study results available
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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).

Conditions

  • Myelofibrosis With Myeloid Metaplasia
  • Myeloid Metaplasia
  • Myelofibrosis

Interventions

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

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Robert Peter Gale, MD, PhD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-01
Primary Completion
2009-05-01
Completion
2013-12-31

Countries

  • United States
  • Austria
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463385 on ClinicalTrials.gov