Momelotinib Effectiveness in Myelofibrosis

November 18, 2025 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for primary myelofibrosis or post polycythemia vera or post essential thrombocythemia at the Italian hemathology units with access to momelotinib. All participating centers belong to the GIMEMA network.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MF patients treated with momelotinib
Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis treated with momelotinib according to clinical practice from AIFA authorization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Francesco Passamonti, Ematologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2026

Primary Completion (Estimated)

January 2, 2028

Study Completion (Estimated)

April 2, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPN0325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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