Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

This research study, called SUCCESSOR-2, is for people in the UK who have multiple myeloma that has returned or stopped responding to past treatments. The main goal is to test if adding a new medicine called Mezigdomide to a standard treatment of Carfilzomib and Dexamethasone works better. Participants will be divided into two groups: one will receive the new three-medicine combination (Mezigdomide, Carfilzomib, and Dexamethasone), and the other will receive the standard two-medicine combination (Carfilzomib and Dexamethasone). By comparing these groups, researchers hope to find out if the new combination is more effective at treating multiple myeloma.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

606

Start

10 Jan 2023

Estimated completion

25 Jul 2029

Relapsed or Refractory Multiple Myeloma

What is this study about?

This study is a clinical trial for people in the UK who have a type of blood cancer called multiple myeloma. Multiple myeloma affects cells in your bone marrow and can cause various health problems. Sometimes, after initial treatment, the cancer might come back (this is called 'relapsed') or it might not respond well to the treatments you've had (this is called 'refractory'). This trial is specifically for people facing these situations, looking for new and potentially better ways to manage their condition.

The researchers want to compare two different treatment approaches. One approach is a combination of two established medicines, Carfilzomib and Dexamethasone. The other approach adds a new medicine called Mezigdomide to this standard combination. By comparing these two groups, doctors hope to understand if the new three-drug combination is more effective at controlling the myeloma, improving people's health, or reducing side effects compared to the established two-drug combination.

Taking part in a study like this helps improve our understanding of multiple myeloma and can lead to new treatment options for others in the future. The trial is in 'Phase 3,' which means it's a large study, and if the new treatment works well, it could become a standard treatment option for people with relapsed or refractory multiple myeloma.

Key takeaways

This study is testing a new combination of medicines for multiple myeloma.
It's for people whose myeloma has come back or isn't responding to past treatments.
The new combination includes Mezigdomide, Carfilzomib, and Dexamethasone.
Participants will be compared to those receiving Carfilzomib and Dexamethasone alone.
The goal is to find out if the new combination is more effective.

Who may be eligible?

To be able to join this study, people must have a clear diagnosis of multiple myeloma that can be measured by medical tests. This means their recent blood or urine tests should show specific levels of myeloma-related proteins or changes in certain blood cells.

Participants must have already received at least one prior treatment for their multiple myeloma. Importantly, they must have previously taken a medicine called lenalidomide and had at least two cycles of a medicine known as an anti-CD38 monoclonal antibody. If they couldn't tolerate the anti-CD38 medicine and had less than two cycles, they might still be eligible. It's also necessary that their myeloma showed some improvement with at least one past treatment, but then either worsened or stayed the same after their very last treatment course.

There are also some reasons why someone might not be able to join. For example, if you've ever had Mezigdomide or Carfilzomib before, you cannot participate. Also, if you've had certain types of stem cell transplants recently or at any point for specific transplant types, you might not be eligible. The study has other specific rules about who can and cannot join to ensure safety and that the results are accurate.

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.

Do you have a clear diagnosis of multiple myeloma that can be measured?
Have you already had at least one treatment for your multiple myeloma?
Have you previously taken lenalidomide and an anti-CD38 medicine?
Did your myeloma show some improvement with past treatment, but has now progressed or not responded?
Have you never had Mezigdomide or Carfilzomib before?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the standard two-medicine combination or the new three-medicine combination. The study will involve regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. This may include tests to see how your multiple myeloma is responding.

You will be closely monitored for any side effects from the medicines. The exact number of visits and the total duration of your participation will depend on how you respond to the treatment and the study plan, but you should expect to attend regularly for a period. After the treatment phase, there will likely be follow-up appointments to track your long-term health. All study-related medication and tests would be provided as part of your participation.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new medicine that could be more effective for your multiple myeloma. Your health will be closely monitored by a dedicated medical team. However, like all medicines, those used in this study can have side effects, and adding a new medicine might introduce new or different side effects compared to standard treatment. It's important to understand that the new medicine might not be more effective, or it might not work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (207)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0046
Verified postcode
Mobile, United States
Local Institution - 0005
Verified postcode
Cerritos, United States
Local Institution - 0190
Verified postcode
Irvine, United States
Local Institution - 0187
Verified postcode
Los Angeles, United States
Local Institution - 0344
Verified postcode
Santa Rosa, United States
Local Institution - 0339
Verified postcode
Stockton, United States
Local Institution - 0279
Verified postcode
Newark, United States
Local Institution - 0341
Verified postcode
Fort Myers, United States
Local Institution - 0342
Verified postcode
St. Petersburg, United States
Local Institution - 0340
Verified postcode
West Palm Beach, United States
Local Institution - 0348
Verified postcode
Atlanta, United States
Local Institution - 0291
Verified postcode
Atlanta, United States

Common questions

What is multiple myeloma?

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

What does 'relapsed or refractory' mean?

'Relapsed' means your myeloma has come back after treatment, and 'refractory' means your myeloma has not responded or has progressed despite treatment.

What are Mezigdomide, Carfilzomib, and Dexamethasone?

These are all medicines used to treat multiple myeloma, either alone or in combination. Mezigdomide is an investigational drug being tested in this study.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which specific treatment you are receiving until later.

What is a 'Phase 3' study?

A Phase 3 study is a large clinical trial that compares a new treatment with an existing one to see if it's better, or if it works and is safe enough to become a standard treatment.