Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
This UK study is looking at a new treatment combination for multiple myeloma, a type of blood cancer. It's for people whose myeloma has returned or isn't responding to their current treatments. The combination includes a new drug called inobrodib, along with two existing medicines, pomalidomide and dexamethasone. The main goal is to find out how effective this combination is at fighting the cancer cells and to better understand any side effects. There won't be a comparison group, meaning everyone in the study will receive this new combination, and they will know what treatment they are getting. This research is important for finding new ways to help people living with multiple myeloma when standard therapies are no longer working.
Auf einen Blick
Worum geht es in dieser Studie?
This study is a clinical trial, which means it's a careful medical research study involving people. The main purpose of this particular study is to explore a new way to treat multiple myeloma, a cancer that affects plasma cells in your blood and bone marrow. Specifically, it's for people whose multiple myeloma has returned after previous treatments (called 'relapsed') or is no longer responding to existing treatments (called 'refractory').
The study is testing a combination of three medicines: inobrodib (which is a new medicine), pomalidomide, and dexamethasone. Pomalidomide and dexamethasone are already used to treat multiple myeloma. Researchers want to see if adding inobrodib to these two medicines can be a better way to fight the cancer. They are particularly interested in how well this combination shrinks or controls the cancer and what side effects people might experience.
This is a 'Phase 2' study, which means the medicines have already passed initial safety tests, and now the focus is more on how well they work and to gather more information about side effects. About 100 people will take part. Participants will know which treatment they are receiving, and there won't be a group receiving a different treatment for comparison. The medicines will be given until the cancer gets worse, new treatment is needed, side effects become too strong, or if you or your doctor decide it’s best to stop.
Wichtige Erkenntnisse
- This study tests a new combination for multiple myeloma that has returned or stopped responding to past treatments.
- The new combination includes inobrodib, pomalidomide, and dexamethasone.
- It's a Phase 2 study focused on how well the treatment works and what side effects it causes.
- You would take tablets as an oral medication on specific schedules within 28-day cycles.
- Regular hospital visits, blood tests, and scans will monitor your health and treatment's effects.
- You can stop participating at any time without affecting your standard care.
Wer könnte berechtigt sein?
To join this study, you need to be at least 18 years old and have a diagnosis of multiple myeloma that has come back or is no longer responding to your last treatment. You also need to be generally well enough to take part in a study, which doctors can check with simple daily activities and blood tests.
There are also some specific requirements for previous treatments. You must have tried at least one 'proteosome inhibitor' medicine, one 'anti-CD38 monoclonal antibody' medicine, and pomalidomide, and your cancer must have stopped responding to them. You also need to have been treated with a specific type of immunotherapy called a 'bispecific T-cell engager' before considering this study.
However, you cannot join if you are pregnant or breastfeeding, or if you've recently had major surgery or received certain other experimental treatments. If you have severe allergies to the study medicines, other active cancers, or other serious health problems that might make taking part risky or unreliable, you also won't be able to join. Your doctor will carefully review all your medical information to see if this study is right for you.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie 18 Jahre alt oder älter?
- Has your multiple myeloma come back or stopped responding to your last treatment?
- Have you previously tried specific treatments like a 'proteosome inhibitor', an 'anti-CD38 antibody', pomalidomide, and a 'bispecific T-cell engager'?
- Are you generally well and able to manage daily activities?
- Sind Sie nicht schwanger oder stillen Sie nicht?
- Do you have any serious allergies to the study medications?
Was beinhaltet die Teilnahme?
If you join this study, you'll be taking three medicines: inobrodib, pomalidomide, and dexamethasone. Inobrodib will be taken as a tablet by mouth, twice a day, for 4 days, then you'll have 3 days off, and this cycle repeats every 28 days. Pomalidomide will also be a tablet taken once a day for the first 21 days of each 28-day cycle. Dexamethasone will be a tablet taken once a day on specific days (1, 8, 15, and 22) within each 28-day cycle.
You will continue taking these medicines as long as the treatment is helping, side effects are manageable, or until your doctor decides it's no longer the best option. During the study, you'll have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study team will explain exactly how often these visits will be and what they will involve.
Potenzielle Risiken und Vorteile
Standorte (31)
- Mayo Clinic ArizonaVerifizierte PostleitzahlPhoenix, Vereinigte Staaten· Rekrutierung
- Universität von Kalifornien, San FranciscoVerifizierte PostleitzahlSan Francisco, Vereinigte Staaten· Rekrutierung
- Mayo Clinic FloridaVerifizierte PostleitzahlJacksonville, Vereinigte Staaten· Rekrutierung
- H Lee Moffitt Cancer Center & Research InstituteVerifizierte PostleitzahlTampa, Vereinigte Staaten· Rekrutierung
- Winship Cancer InstituteVerifizierte PostleitzahlAtlanta, Vereinigte Staaten· Rekrutierung
- University of Chicago Medical CenterVerifizierte PostleitzahlChicago, Vereinigte Staaten· Rekrutierung
- University of Iowa Health CareVerifizierte PostleitzahlIowa City, Vereinigte Staaten· Rekrutierung
- American Oncology Partners, PAVerifizierte PostleitzahlBethesda, Vereinigte Staaten· Rekrutierung
- Dana-Farber Cancer InstituteVerifizierte PostleitzahlBoston, Vereinigte Staaten· Rekrutierung
- Universität von MichiganVerifizierte PostleitzahlAnn Arbor, Vereinigte Staaten· Rekrutierung
- Mayo ClinicVerifizierte PostleitzahlRochester, Vereinigte Staaten· Rekrutierung
- Washington University School of MedicineVerifizierte PostleitzahlSt. Louis, Vereinigte Staaten· Rekrutierung
Häufige Fragen
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.
What does 'relapsed or refractory' mean?
It means the cancer has come back after treatment (relapsed) or is no longer responding to treatments it was previously responding to (refractory).
What are inobrodib, pomalidomide, and dexamethasone?
Inobrodib is a new experimental medicine. Pomalidomide and dexamethasone are existing medicines often used to treat multiple myeloma.
Will I know which treatment I am getting?
Yes, everyone in this study will receive the combination of inobrodib, pomalidomide, and dexamethasone, and you will know this from the start.
How long will I be on the treatment?
You will continue treatment as long as it's helping and the side effects are acceptable, or until your doctor decides it's time to stop.
Wie Sie mehr erfahren können
CCS1477-04 Clinical Operations
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