Momelotinib Effectiveness in Myelofibrosis

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07249606

Enrollment

Registered

2025-11-25

Start date

2026-01-02

Completion date

2028-04-02

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis (MF)

Keywords

Myelofibrosis, momelotinib, real-world, post polycythemia, post essential thrombocythemia

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients aged 18 years or older. 2. Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization. 3. Patients with palpable splenomegaly at baseline of momelotinib treatment. 4. Informed consent signed, if applicable.

Exclusion criteria

1. Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera. 2. Accelerated/blast phase of MF. 3. Patients with platelets \<20 x10(9)/L at baseline of MMB treatment. 4. Patients JAK inhibitors-exposed for other diseases apart from MF.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of momelotinib in splenic response improving	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.

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it+390670390528

Backup ContactEnrico Crea

e.crea@gimema.it+390670390514

Outcome results