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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

This important UK research study is looking for volunteers with a type of blood cancer called multiple myeloma. Specifically, it's for those whose myeloma has returned or isn't responding well to their current treatments. The study is investigating a new medicine called sonrotoclax. Doctors want to understand how safe this new drug is and how well it works. They will test it by itself and in combination with other established multiple myeloma medications like Dexamethasone, Carfilzomib, Daratumumab, and Pomalidomide. The aim is to find better ways to treat this condition, especially for people with a specific change in their cancer cells known as a t(11;14) translocation.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
BeOne Medicines
Enrolment target
246
Start
16 Sep 2021
Estimated completion
01 Nov 2026

What is this study about?

This research study is focused on a type of blood cancer called multiple myeloma. It's for people in the UK whose myeloma has either come back after treatment (relapsed) or isn't getting better with their current medicines (refractory). The main goal is to test a new drug called sonrotoclax. We want to understand if sonrotoclax is safe to use and how effective it is at treating multiple myeloma.

The study will look at sonrotoclax in a few different ways. Some participants might receive sonrotoclax on its own. Others might get sonrotoclax combined with a common steroid medicine called dexamethasone, and then also with other established myeloma drugs like carfilzomib, daratumumab, or pomalidomide. By testing these combinations, doctors hope to find the best ways to use sonrotoclax to help people with multiple myeloma.

A key part of this study is that it's specifically for people whose multiple myeloma cells have a particular genetic change called a t(11;14) translocation. This is important because sonrotoclax is designed to work well for myeloma with this specific change. The aim is to discover new and better treatment options for those who haven't responded to previous treatments or whose cancer has returned.

Key takeaways

  • This study is for adults with multiple myeloma that has returned or isn't responding to treatment.
  • It's testing a new drug called sonrotoclax, alone and in combination with other myeloma medicines.
  • Participants must have a specific genetic change in their myeloma cells called t(11;14) translocation.
  • The aim is to find new and more effective ways to treat this type of blood cancer.
  • You will have regular check-ups and tests if you take part.

Who may be eligible?

For this study, we are looking for adults aged 18 or over. You must have been diagnosed with multiple myeloma and have measurable levels of the disease. This means your doctors can track how your myeloma is responding to treatment using blood or urine tests.

Your multiple myeloma must have either returned after previous treatments or not responded adequately to your most recent therapy. You will also need to have a specific genetic change in your myeloma cells, called a t(11;14) translocation, which your doctor can check with a special test.

Depending on which part of the study you might join, there are different requirements for how many previous treatments you've had. For some parts, you will need to have had at least three prior treatments, including specific types of drugs. For other parts, having had one or more prior treatments might be enough. Your overall health and organ function (like your blood counts and kidney function) also need to be good enough to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 or older with a confirmed diagnosis of multiple myeloma?
  2. Has your multiple myeloma come back or stopped responding to previous treatments?
  3. Do you know if your myeloma cells have a t(11;14) genetic change?
  4. Are you generally well enough for a clinical study, with stable organ function?
  5. Have you had at least one previous treatment for your multiple myeloma?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication (sonrotoclax and/or other approved drugs) as instructed by the research team. This will involve regular visits to the clinic for medical check-ups, blood and urine tests, and other assessments like bone marrow samples. These tests help doctors monitor your health, how the treatment is working, and if you experience any side effects.

The frequency and duration of your visits will depend on which part of the study you are in and how you respond to treatment. You will be closely monitored throughout the study. The total duration of your participation will vary, but it involves ongoing treatment and follow-up to ensure your safety and to understand the long-term effects of the medication.

Potential risks and benefits

Patients who take part in this study might benefit from receiving a new treatment that could help control their multiple myeloma when other options haven't worked or are no longer effective. This new treatment might also have different side effects compared to standard therapies. However, as with all new medicines, there's always a chance it might not work for everyone, or it could cause side effects that are not yet fully known. The research team will carefully monitor you for any potential side effects throughout the study. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (84)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama At Birmingham Hospital
    Verified postcode
    Birmingham, United States· Recruiting
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States· Recruiting
  • City of Hope Irvine Lennar
    Verified postcode
    Irvine, United States· Recruiting
  • University of Miami
    Verified postcode
    Miami, United States· Recruiting
  • Emory University Winship Cancer Center
    Verified postcode
    Atlanta, United States· Recruiting
  • University of Chicago Medical Center
    Verified postcode
    Chicago, United States· Recruiting
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States· Completed
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States· Recruiting
  • Hackensack University Medical Center
    Verified postcode
    Hackensack, United States· Recruiting
  • Weill Cornell Medical College Newyork Presbyterian Hospital
    Verified postcode
    New York, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center Mskcc
    Verified postcode
    New York, United States· Recruiting
  • The James Cancer Hospital and Solove Research Institute At Ohio State University
    Verified postcode
    Columbus, United States· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in your bone marrow.

What does 'relapsed/refractory' mean?

It means your myeloma has either come back after treatment or isn't responding well to the medicines you've been taking.

What is t(11;14) translocation?

This is a specific genetic change that can be found in some multiple myeloma cells, which the new drug in this study is designed to target.

Will I get paid to participate?

Generally, patients in clinical trials are not paid, but your travel expenses to clinic visits will usually be covered.

Who is running this study?

This study is sponsored by BeOne Medicines, previously known as BeiGene, a company that develops new medications.

How to find out more

BeOne Medicines

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 "A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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