Status:
COMPLETED
A Phase II Study of Pomalidomide in Myelofibrosis With Myeloid Metaplasia
Lead Sponsor:
Celgene
Conditions:
Myelofibrosis With Myeloid Metaplasia
Myeloid Metaplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 patient...
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 un...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00463385
Start Date
April 1 2007
End Date
December 31 2013
Last Update
November 20 2019
Active Locations (11)
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1
UCLA School of Medicine Hematology/Oncology
Los Angeles, California, United States, 90095
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021-6007
4
New York Presbyterian HospitalWeill Medical College of Cornell University
New York, New York, United States, 10021