Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
NCT ID: NCT01969838
Last Updated: 2023-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
432 participants
INTERVENTIONAL
2013-12-06
2019-05-02
Brief Summary
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Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Momelotinib
Participants will receive momelotinib plus placebo to match ruxolitinib.
Momelotinib
Momelotinib tablet administered orally once daily
Placebo to match ruxolitinib
Placebo to match ruxolitinib tablets administered orally twice daily
Ruxolitinib
Participants will receive ruxolitinib plus placebo to match momelotinib.
Ruxolitinib
Ruxolitinib tablets administered orally twice daily
Placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once daily
Interventions
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Momelotinib
Momelotinib tablet administered orally once daily
Ruxolitinib
Ruxolitinib tablets administered orally twice daily
Placebo to match momelotinib
Placebo to match momelotinib tablets administered orally once daily
Placebo to match ruxolitinib
Placebo to match ruxolitinib tablets administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of PMF or post-PV/ET MF
* Requires myelofibrosis therapy, in the opinion of the investigator
* Classified as high risk OR intermediate-2 risk as defined by the International Prognostic Scoring System (IPSS) for PMF, or intermediate-1 risk (IPSS) associated with symptomatic splenomegaly, hepatomegaly, anemia (hemoglobin \< 10.0 g/dL), and/or unresponsive to available therapy
* Acceptable laboratory assessment obtained within 14 days prior to the first dose of study drug:
* Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9/L in the absence of growth factor in the prior 7 days
* Platelet Count ≥ 50 x 10\^9/L (≥ 100 x 10\^9/L if aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] is ≥ 2 x the upper limit of the normal range \[ULN\]) in the absence of platelet transfusion(s) or thrombopoietin mimetics in the prior 7 days
* Peripheral blood blast count \< 10%
* AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
* Calculated creatinine clearance (CrCL) of ≥ 45 mL/min
* Direct bilirubin ≤ 2.0 x ULN
* Life expectancy of \> 24 weeks
* Males and females of childbearing potential must agree to use protocol-specified method(s) of contraception
* Females who are nursing must agree to discontinue nursing before the first dose of study drug
* Able to understand and willing to sign the informed consent form
Exclusion Criteria
* Splenic irradiation within 3 months prior to the first dose of study drug
* Eligible for allogeneic bone marrow or stem cell transplantation
* Uncontrolled inter-current illness, per protocol.
* Known positive status for human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection, or a hepatitis B or C carrier
* Prior use of a JAK1 or JAK2 inhibitor
* Use of chemotherapy, immunomodulating therapy, biologic therapy, radiation therapy, or investigational therapy within 4 weeks of the first dose of study drug
* Presence of peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
* Unwilling or unable to undergo a magnetic resonance imaging (MRI) or computed tomography (CT) scan
18 Years
ALL
No
Sponsors
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Sierra Oncology LLC - a GSK company
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Örebro, , Sweden
Stockholm, , Sweden
Uddevalla, , Sweden
Kaohsiung City, , Taiwan
Leicester, England, United Kingdom
London, England, United Kingdom
Manchester, England, United Kingdom
Newcastle upon Tyne, England, United Kingdom
Oxford, England, United Kingdom
Cardiff, Wales, United Kingdom
Northern Ireland, , United Kingdom
Nottingham, , United Kingdom
Phoenix, Arizona, United States
Escondido, California, United States
Stanford, California, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Seattle, Washington, United States
Darlinghurst, New South Wales, Australia
Parkville, New South Wales, Australia
Saint Leonards, New South Wales, Australia
Brisbane, Queensland, Australia
Herston, Queensland, Australia
Adelaide, South Australia, Australia
Bedford Park, South Australia, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Vienna, Vienna, Austria
Charleroi, Hainaut, Belgium
Antwerp, , Belgium
Leuven, , Belgium
Liège, , Belgium
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Hradec Králové, Vychodocesky KRAJ, Czechia
Brno, , Czechia
Ostrava, , Czechia
Aalborg, , Denmark
Herlev, , Denmark
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Toulouse, Midi-pyrenees, France
Le Kremlin-Bicêtre, , France
Lens, , France
Lille, , France
Marseille, , France
Nantes, , France
Paris, , France
Pessac, , France
Villejuif, , France
München, Bavaria, Germany
Leipzig, Saxony, Germany
Dresden, , Germany
Düsseldorf, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Mainz, , Germany
Mannheim, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Kaposvár, , Hungary
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Jerusalem, , Israel
Tel Aviv, , Israel
Ōgaki, Gifu, Japan
Kitaku Sapporo, Hokkaido, Japan
Osaka, Osaka, Japan
Ōsaka-sayama, Osaka, Japan
Bunkyo-ku, Tokyo, , Japan
Fukushima, , Japan
Kumamoto, , Japan
Matsuyama, , Japan
Okayama, , Japan
Maastricht, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Poznan, Greater Poland Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Lublin, Lublin Voivodeship, Poland
Warsaw, Mazowiekie, Poland
Gdansk, Pomeranian Voivodeship, Poland
Bialystok, , Poland
Brzozów, , Poland
Chorzów, , Poland
Lodz, Łódź Voivodeship, Poland
Arad, , Romania
Brasov, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Singapore, , Singapore
Seoul, , South Korea
Majadahonda, Madrid, Spain
Pamplona, Navarre, Spain
Badalona, , Spain
Barcelona, , Spain
Valencia, , Spain
Zaragoza, , Spain
Lund, Skåne County, Sweden
Countries
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References
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Mesa RA, Talpaz M, Mazerolle F, Gorsh B, M'Hari M, Regnault A, Ellis C, Wang Z, Purser M, Liu T, Strouse B, Patnaik D. Time Without Transfusion Reliance (TWiTR): Integrating Survival Quality Into Myelofibrosis Treatment Strategies Based on the Phase 3 SIMPLIFY-1, SIMPLIFY-2, and MOMENTUM Trials. EJHaem. 2025 Jun 18;6(3):e70075. doi: 10.1002/jha2.70075. eCollection 2025 Jun.
Harrison CN, Mesa R, Talpaz M, Gupta V, Gerds AT, Perkins A, Goh YT, Fox ML, McLornan D, Palmer J, Foltz L, Vannucchi A, Koschmieder S, Passamonti F, Lee SE, Ellis C, Strouse B, Gonzalez Carreras FJ, Oh ST. Longitudinal Assessment of Transfusion Intensity in Patients With JAK Inhibitor-Naive or -Experienced Myelofibrosis Treated With Momelotinib. Clin Lymphoma Myeloma Leuk. 2025 Mar;25(3):199-211. doi: 10.1016/j.clml.2024.10.001. Epub 2024 Oct 16.
Verstovsek S, Mesa R, Gupta V, Lavie D, Dubruille V, Cambier N, Platzbecker U, Hus M, Xicoy B, Oh ST, Kiladjian JJ, Vannucchi AM, Gerds A, Egyed M, Mayer J, Sacha T, Kawashima J, Morris M, Huang M, Harrison C. Momelotinib long-term safety and survival in myelofibrosis: integrated analysis of phase 3 randomized controlled trials. Blood Adv. 2023 Jul 25;7(14):3582-3591. doi: 10.1182/bloodadvances.2022009311.
Other Identifiers
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2013-002707-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-352-0101
Identifier Type: -
Identifier Source: org_study_id
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