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About
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).
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.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Palpable splenomegaly at least 5 cm below the left costal margin
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:
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
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
432 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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