Momelotinib Effectiveness in Myelofibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myelofibrosis (MF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)
Overview
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.
Primary outcome measures
- Efficacy of momelotinib in splenic response improving [Time frame: Six months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07249606 · MPN0325