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NCT Number: NCT07249606

Momelotinib Effectiveness in Myelofibrosis

Observational study aimed at evaluating the use of momelotinib in patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) in a real-world setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a multicenter prospective and retrospective observational clinical study in adult patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) being treated with momelotinib in a real-world setting. The aim of the study is to evaluate the efficacy of momelotinib in terms of splenic response. All patients are managed according to the clinical practice of the participating Center.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization.
  • Patients with palpable splenomegaly at baseline of momelotinib treatment.
  • Informed consent signed, if applicable.

Exclusion criteria

  • Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.
  • Accelerated/blast phase of MF.
  • Patients with platelets <20 x10(9)/L at baseline of MMB treatment.
  • Patients JAK inhibitors-exposed for other diseases apart from MF.

Treatment and study plan

Primary outcomes

  1. Efficacy of momelotinib in splenic response improving

    Time frame: Six months

    To assess the splenic response in terms of rate of patients with more or equal than 50% palpatory reduction compared to baseline at 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Crea

CONTACT

[email protected]

+390670390514

Paola Fazi

CONTACT

[email protected]

+390670390528

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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