Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF
NCT ID: NCT02101268
Last Updated: 2023-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2014-06-19
2019-04-25
Brief Summary
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Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 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 subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 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
NONE
Study Groups
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Arm 1: Momelotinib
Participants will receive open-label momelotinib for 24 weeks during the randomized treatment phase, after which they will be eligible to receive momelotinib in an extended treatment phase for up to an additional 204 weeks.
Momelotinib
Momelotinib tablet administered orally once daily
Arm 2: Best Available Therapy (BAT)
Participants in the BAT treatment arm will receive open-label treatment at doses and schedules determined by the investigator in accordance with standard of care. Therapy may be changed at any time during the study except during the screening period. After completion of the randomized treatment phase, participants will be eligible to receive momelotinib for the duration of the study during the extended treatment phase for up to 204 weeks.
Best Available Therapy (BAT)
Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.
Interventions
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Momelotinib
Momelotinib tablet administered orally once daily
Best Available Therapy (BAT)
Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of PMF in accordance, or Post-PV/ET MF
* Currently or previously treated with ruxolitinib for PMF or Post-PV/ET MF for at least 28 days, and characterized by
* Requirement for RBC transfusion while on ruxolitinib treatment, OR
* Dose adjustment of ruxolitinib to \< 20 mg twice daily at start of or during ruxolitinib treatment AND at least one of the following while on ruxolitinib treatment:
* ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 thrombocytopenia, OR
* ≥ CTCAE Grade 3 anemia, OR
* ≥ CTCAE Grade 3 hematoma (bleed)
* High risk OR intermediate-2 risk as defined by Dynamic International Prognostic Scoring System (DIPSS), OR intermediate-1 risk as defined by DIPSS and associated with symptomatic splenomegaly, and/or hepatomegaly
* If receiving myelofibrosis therapy, must be on a stable dose of the same regimen for at least 2 weeks prior to screen date and through the screening period
* If not receiving myelofibrosis therapy, must remain off therapy for at least 2 weeks prior to screen date and through the screening period
* Acceptable laboratory assessments obtained within 14 days prior to Randomization
* Absolute neutrophil count (ANC) \> 0.75 x 10\^9/L in the absence of growth factor in the prior 7 days
* Peripheral blood blast count \< 10%
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x the upper limit of the normal range (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 of ≥ 45 mL/min
* Direct bilirubin ≤ 2.0 x ULN
* Life expectancy \> 24 weeks
* Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)
* 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 MMB
* Able to understand and willing to sign informed consent form (ICF)
Exclusion Criteria
* Splenic irradiation within 3 months prior to Randomization
* Use of investigational agent within 28 days prior to Randomization
* Prior treatment with MMB
* Hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) within 28 days prior to Randomization
* 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 hepatitis B or C carrier
* Presence of peripheral neuropathy ≥ CTCAE Grade 2
* Unwilling or unable to undergo a MRI or CT Scan per study protocol requirements
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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Los Angeles, California, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Kansas City, Kansas, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Montreal, , Canada
Toronto, , Canada
Lille, , France
Marseille, , France
Nantes, , France
Paris, , France
Pierre-Bénite, , France
Toulouse, , France
Villejuif, , France
Cologne, , Germany
Dresden, , Germany
Hamburg, , Germany
Mannheim, , Germany
Ashkelon, , Israel
Haifa, , Israel
Jerusalem, , Israel
Tel Aviv, , Israel
Bologna, , Italy
Florence, , Italy
Genova, , Italy
Milan, , Italy
Novara, , Italy
Roma, , Italy
Varese, , Italy
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Salamanca, , Spain
Valencia, , Spain
Zaragoza, , Spain
Birmingham, England, United Kingdom
Leeds, England, United Kingdom
Leicester, England, United Kingdom
London, England, United Kingdom
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.
Harrison CN, Vannucchi AM, Recher C, Passamonti F, Gerds AT, Hernandez-Boluda JC, Yacoub A, Sirhan S, Ellis C, Patel B, Strouse B, Platzbecker U. Momelotinib versus Continued Ruxolitinib or Best Available Therapy in JAK Inhibitor-Experienced Patients with Myelofibrosis and Anemia: Subgroup Analysis of SIMPLIFY-2. Adv Ther. 2024 Sep;41(9):3722-3735. doi: 10.1007/s12325-024-02928-4. Epub 2024 Jul 11.
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.
Harrison CN, Vannucchi AM, Platzbecker U, Cervantes F, Gupta V, Lavie D, Passamonti F, Winton EF, Dong H, Kawashima J, Maltzman JD, Kiladjian JJ, Verstovsek S. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): a randomised, open-label, phase 3 trial. Lancet Haematol. 2018 Feb;5(2):e73-e81. doi: 10.1016/S2352-3026(17)30237-5. Epub 2017 Dec 20.
Other Identifiers
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2013-005007-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-352-1214
Identifier Type: -
Identifier Source: org_study_id
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