Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
Prospective, Longitudinal, Non-Interventional Study of Disease Burden and Treatment of Patients With Low-Risk Myelofibrosis (MF) or High-Risk Essential Thrombocythemia (ET) or ET Patients Receiving ET-Directed Therapy
1 other identifier
observational
1,469
2 countries
116
Brief Summary
The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
December 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2022
CompletedMay 13, 2022
May 1, 2022
5.2 years
November 1, 2016
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients
Approximately every 6 months through end of study, up to approximately 36 months
Secondary Outcomes (9)
Description of patterns of treatment, therapies, and clinical management
Approximately every 3-6 months through end of study, up to at least 36 months
Description of disease progression over time
Approximately every 3-6 months through end of study, up to at least 36 months
Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time
Approximately every 3-6 months through end of study, up to at least 36 months
Description of the comorbidities associated with disease and progression
Approximately every 3-6 months through end of study, up to at least 36 months
Description of changes in patient-reported symptoms and quality of life (QOL)
Approximately every 3-6 months through end of study, up to at least 36 months
- +4 more secondary outcomes
Study Arms (2)
Myelofibrosis Cohort
Patients will be categorized as low-risk using Dynamic International Prognostic Scoring System (DIPSS) risk OR intermediate-1 risk by DIPSS by reason of age alone.
Essential Thrombocythemia Cohort
Patients will be age ≥ 60 years OR have history of thromboembolic events OR currently receiving ET-directed therapy.
Eligibility Criteria
Subjects will be enrolled from up to 250 community and academic centers across the United States.
You may qualify if:
- MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.
- ET cohort: Diagnosis of ET and age ≥ 60 years OR history of thromboembolic events OR currently receiving ET-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc).
- Willing and able to provide written informed consent.
- Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel.
- Under the supervision of a physician for the current care of MF or ET.
You may not qualify if:
- Individuals who are participating in blinded investigational drug studies.
- Individuals who are participating in Incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit.
- Life expectancy ≤ 6 months.
- Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
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Huntsville, Alabama, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Highland, California, United States
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Long Beach, California, United States
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Oceanside, California, United States
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Palo Alto, California, United States
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Santa Rosa, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Middletown, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Winter Haven, Florida, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Thomasville, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Elk Grove Village, Illinois, United States
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Harvey, Illinois, United States
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Maywood, Illinois, United States
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Normal, Illinois, United States
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River Forest, Illinois, United States
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Skokie, Illinois, United States
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Anderson, Indiana, United States
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Avon, Indiana, United States
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Indianapolis, Indiana, United States
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Terre Haute, Indiana, United States
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Ames, Iowa, United States
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Topeka, Kansas, United States
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Westwood, Kansas, United States
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Danville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Paducah, Kentucky, United States
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Alexandria, Louisiana, United States
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Covington, Louisiana, United States
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Marrero, Louisiana, United States
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Rockport, Maine, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Lansing, Michigan, United States
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Jackson, Minnesota, United States
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Lansing, Minnesota, United States
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Bolivar, Missouri, United States
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Cape Girardeau, Missouri, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Kalispell, Montana, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Brick, New Jersey, United States
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East Orange, New Jersey, United States
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Florham Park, New Jersey, United States
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Morristown, New Jersey, United States
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Paramus, New Jersey, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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East Setauket, New York, United States
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Elmira, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Boone, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Hendersonville, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Tualatin, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Dunmore, Pennsylvania, United States
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Gettysburg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Lancaster, South Carolina, United States
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Spartanburg, South Carolina, United States
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Watertown, South Dakota, United States
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Jackson, Tennessee, United States
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Amarillo, Texas, United States
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Arlington, Texas, United States
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Beaumont, Texas, United States
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Bryan, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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McKinney, Texas, United States
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Mesquite, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Bristol, Virginia, United States
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Seattle, Washington, United States
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Yakima, Washington, United States
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Martinsburg, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Bayamón, Puerto Rico
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Ponce, Puerto Rico
Related Publications (3)
Ritchie E, Al-Janadi A, Kessler C, Scherber R, Kalafut T, Ren H, Mesa R. Patient-reported outcomes of patients with myelofibrosis or essential thrombocythemia enrolled in the MOST study. Leuk Lymphoma. 2022 Dec;63(13):3138-3153. doi: 10.1080/10428194.2022.2113531. Epub 2022 Oct 7.
PMID: 36205505DERIVEDGerds AT, Lyons RM, Colucci P, Kalafut P, Paranagama D, Verstovsek S. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Myelofibrosis Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):e532-e540. doi: 10.1016/j.clml.2022.02.001. Epub 2022 Feb 8.
PMID: 35256316DERIVEDYacoub A, Lyons R, Verstovsek S, Shao R, Chu DT, Agrawal A, Sivaraman S, Colucci P, Paranagama D, Mascarenhas J. Disease and Clinical Characteristics of Patients With a Clinical Diagnosis of Essential Thrombocythemia Enrolled in the MOST Study. Clin Lymphoma Myeloma Leuk. 2021 Jul;21(7):461-469. doi: 10.1016/j.clml.2021.02.011. Epub 2021 Mar 1.
PMID: 33839074DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robyn M. Scherber, MD, MPH
Incyte Corporation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
November 3, 2016
Study Start
December 31, 2016
Primary Completion
March 29, 2022
Study Completion
March 29, 2022
Last Updated
May 13, 2022
Record last verified: 2022-05