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RecruitingPHASE2INTERVENTIONAL

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.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
CellCentric Ltd.
Enrolment target
100
Start
22 Jan 2026
Estimated completion
01 Dec 2029

What is this study about?

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.

Key takeaways

  • 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.

Who may be eligible?

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.

Quick self-check
  • Are you 18 years old or older?
  • 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?
  • Are you not pregnant or breastfeeding?
  • Do you have any serious allergies to the study medications?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

Participating in any clinical study carries both potential benefits and risks. You might benefit from a new treatment combination that could help control your multiple myeloma when other options are no longer effective. However, there's no guarantee the treatment will work for you, and like all medicines, these drugs can cause side effects. These could range from mild to more serious, and the study will be carefully monitoring them. Your safety and well-being are the top priority. It's very important to remember that joining is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

  • University of California, San Francisco
    San Francisco, United States· Recruiting
  • H Lee Moffitt Cancer Center & Research Institute
    Tampa, United States· Recruiting
  • Winship Cancer Institute
    Atlanta, United States· Recruiting
  • American Oncology Partners, PA
    Bethesda, United States· Recruiting
  • Washington University School of Medicine
    St Louis, United States· Recruiting
  • University of Nebraska Medical Center
    Omaha, United States· Recruiting
  • Rutgers Cancer Institute of New Jersey
    New Brunswick, United States· Recruiting
  • Levine Cancer Institute
    Charlotte, United States· Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, United States· Recruiting
  • Cleveland Clinic
    Cleveland, United States· Recruiting
  • University of Pennsylvania, Abramson Cancer Center
    Philadelphia, United States· Recruiting
  • Fred Hutchinson Cancer Center
    Seattle, United States· Recruiting

+8 more sites — see the official record for the full list.

Common questions

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.

How to find out more

CCS1477-04 Clinical Operations

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Ref…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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