This clinical trial is testing an investigational drug called selinexor for adults with previously treated myelofibrosis.
Selinexor tablets are taken orally (by mouth). Before a drug can be approved for use by a health authority or regulatory agency to treat a specific disease or condition, it must be studied in clinical trials like this one. Selinexor is not approved as a treatment for myelofibrosis.
The main goals of this trial are:
To learn more about selinexor for patients with myelofibrosis. In particular, researchers will look at whether selinexor helps reduce spleen size and improve myelofibrosis symptoms compared with currently available treatments.
You can learn more about whether you might be eligible to join the trial by answering some screening questions (click the “Get Started” button on this page). Your doctor can also help you determine whether this trial might be a good fit for you.
If you are interested in joining this trial, you will need to visit a trial site. Someone from the trial site will explain the trial to you. If you agree to join, the doctors and other site staff will give you an exam and ask you questions about your myelofibrosis and your medical history to make sure you are eligible.
People who join the trial will be randomly assigned to receive either selinexor or a physician’s choice of treatment.
You will receive your assigned study treatment until your myelofibrosis gets worse or you decide to leave the trial. The trial doctor or the trial sponsor also has the right to discontinue a participant for safety issues or if the participant no longer meets the trial requirements. The entire trial is expected to last about 3 or 4 years.
During the trial, you will visit the trial site about once a month for a check-up. Every 3 months, the trial doctors will measure the size of your spleen using a noninvasive imaging tool, such as an MRI.
At home, you will be asked to keep track of your myelofibrosis symptoms daily by responding to a few questions on a smartphone. You will also be asked to use a scale each day that tracks your weight and body composition, and to wear a smartwatch that tracks your activity and monitors your sleep. The trial site will loan you a scale and smartwatch for this purpose during the trial. In addition, if you do not have a smartphone, the site will loan you a smartphone to keep track of your myelofibrosis symptoms.
The trial doctors and site staff will explain these and other procedures involved in the trial and answer any questions you might have before you decide whether you want to join.
This trial is being conducted in sites located in Europe and the United States, with the goal of enrolling 112 patients worldwide. For a full list of enrolling sites, please visit the trial listing on ClinicalTrials.gov.