A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia

Completed · Phase 2 · Has a placebo group

Conditions studied: Myelofibrosis With Myeloid Metaplasia, Myeloid Metaplasia, Myelofibrosis

In brief

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).

Key facts

Study ID

NCT00463385

Run by

Celgene

People needed

88

Starts

2007-04-01

Expected to finish

2013-12-31

Last updated by the study team

2019-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must sign an informed consent form
• Must be >18 years of age
• Must be diagnosed with myelofibrosis
• Eligibility is based on local pathology review of bone marrow aspirate and biopsy
• Screening total hemoglobin level < 10g/dL or transfusion-dependent anemia defined as per International Working Group (IWG) criteria.
• Must have adequate organ function as demonstrated by the following ≤ 14 days prior to starting study drug:
• Alanine aminotransferase (ALT; SGPT)/aspartate aminotransferase (AST; SGOT) ≤ 3 x upper limit of normal (ULN), [unless upon judgment of the treating physician, it is believed to be due to extra-medullary hematopoiesis (EMH)].
• Total Bilirubin <3x ULN or Direct Bilirubin <2 x ULN
• Serum creatinine ≤ 2.0 mg/dL
• Absolute neutrophil count ≥ 1,000/μL (≥ 1 x 10\^9/L).
• Platelet count ≥ 50,000 /μL (≥ 50 x 10\^9/L).
• Patients must be willing to receive transfusion of blood products
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at screening.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• No active malignancies with the exception of controlled prostate cancer, basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
• Must agree to follow pregnancy precautions as required per the protocol

You may not qualify if…

• Known positive status for human immunodeficiency virus (HIV), hepatitis B carrier, or active hepatitis C infection.
• Previous untoward reaction to corticosteroid (specifically, prednisone) therapy that was severe enough, in the opinion of the treating physician, to preclude study participation.
• The use of any growth factors, cytotoxic chemotherapeutic agents (e.g. hydroxyurea and anagrelide), corticosteroids, or experimental drug or therapy within a minimum of 28 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better (e.g. alpha interferon may require 84 days of longer or washout).
• Prior therapy with CC-4047 or, lenalidomide or thalidomide for Myelofibrosis with myeloid metaplasia (MMM). (Prior prednisone use as a therapy for MMM is allowed, but not within 28 days of starting CC-4047).
• History of deep vein thrombosis or pulmonary embolism within one year of starting study medication.
• Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Pregnant or lactating females

Where it is running

• UCLA School of Medicine Hematology/Oncology — Los Angeles, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• New York Presbyterian HospitalWeill Medical College of Cornell University — New York, New York, United States
• MD Anderson Cancer Center Leukemia Department — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Medical University of Vienna, Department of Internal Medicine, Hematology — Vienna, Austria
• Fondazione IRCCS Policlinico San Matteo — Pavia, Italy
• IRCCS Policlinico S. Matteo — Pavia, Italy
• Hematology DepartmentHospital Clinic — Barcelona, Spain
• Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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