A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
This important Phase 3 clinical trial is investigating new treatment options for people in the UK living with multiple myeloma. This is a type of blood cancer where myeloma cells have either returned after previous treatment or haven't responded to it (this is called relapsed or refractory multiple myeloma). The study compares two different drug combinations: a new drug called mezigdomide, used with bortezomib and dexamethasone, against another combination featuring pomalidomide, bortezomib, and dexamethasone. All these drugs are designed to fight multiple myeloma. The main goal is to find out if the mezigdomide combination is more effective at treating the cancer and if it has a similar or better safety profile compared to the pomalidomide combination. Participants will be those who have already received one to three different treatments for their myeloma, including lenalidomide.
At a glance
What is this study about?
This study is a Phase 3 clinical trial, which means it's one of the final stages of testing a new treatment before it might be considered for wider use. It's focused on multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. Specifically, it's for people whose myeloma has either come back after previous treatment (relapsed) or hasn't responded well to previous treatments (refractory). This can be a challenging situation, so finding new and effective treatments is very important.
The trial is comparing two different drug combinations. One combination includes a new drug called mezigdomide, along with two established medicines called bortezomib and dexamethasone. The other combination uses pomalidomide (another established drug) with bortezomib and dexamethasone. Both bortezomib and dexamethasone are commonly used in myeloma treatment. By comparing these two drug regimens, researchers hope to determine if the new mezigdomide-containing combination is better at treating the cancer, and if it's safe for patients to use.
Participants in this study will have already received between one and three different treatments for their multiple myeloma, and they will have had a previous treatment that included lenalidomide. This particular focus helps researchers understand how these new combinations work in patients who have experience with other myeloma therapies. The trial aims to provide valuable information that could lead to new treatment options for people living with relapsed or refractory multiple myeloma.
Key takeaways
- Compares a new drug combination with an existing one for multiple myeloma.
- For people whose multiple myeloma has returned or not responded to previous treatments.
- Participants will have tried 1-3 prior treatments, including lenalidomide.
- Aims to find a more effective and safe treatment option.
- This is a Phase 3 clinical trial, a late stage of research.
- Close medical monitoring and support are provided throughout.
Who may be eligible?
To be considered for this study, you would need to have a confirmed diagnosis of multiple myeloma that can be measured, for instance, through blood or urine tests. You should also have tried between one and three different treatments for your myeloma, and at least one of these treatments must have shown a positive effect (even if just a small improvement).
There are also some reasons why you might not be able to join. For example, if your cancer got worse during or very soon after treatment with certain proteasome inhibitors, you might not be eligible. However, there are some specific situations where this rule wouldn't apply, such as if you were on a proteasome inhibitor for maintenance or a long time ago. Also, you cannot have received mezigdomide or pomalidomide before this study.
The research team will carefully review your medical history to make sure the study is a good fit for you. There are other detailed medical criteria they will also check, beyond what's mentioned here.
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 confirmed diagnosis of multiple myeloma?
- Has your multiple myeloma either come back or not responded to previous treatments?
- Have you had between 1 and 3 different treatments for your myeloma already?
- Did at least one of your previous treatments show some positive effect?
- Have you not previously taken the study drugs (mezigdomide or pomalidomide)?
- Are you aged 18 or older?
What does participation involve?
If you take part in this study, you will be assigned to receive one of the two treatment combinations. This will involve regular visits to the clinic for medical check-ups, blood tests, and to receive your medication. The specific number of visits and tests will be detailed by the study team, but typically involve frequent appointments, especially at the beginning of the treatment period, and less frequent check-ups over time. You will be monitored closely for any side effects and to see how well the treatment is working. After the treatment period, there will be a follow-up phase to continue monitoring your health. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but clinical trials often involve several months to a few years of observation.
Potential risks and benefits
Locations (266)
- Local Institution - 0366Verified postcodeLos Alamitos, United States· Active not recruiting
- Local Institution - 0272Verified postcodeSan Diego, United States· Completed
- Local Institution - 0273Verified postcodeWest Hollywood, United States· Completed
- Local Institution - 0381Verified postcodeAurora, United States· Not yet recruiting
- Local Institution - 0380Verified postcodeFarmington, United States· Completed
- Local Institution - 0208Verified postcodeNew Haven, United States· Withdrawn
- Local Institution - 0303Verified postcodeCoral Springs, United States· Active not recruiting
- Local Institution - 0403Verified postcodeFort Myers, United States· Active not recruiting
- Local Institution - 0401Verified postcodeSt. Petersburg, United States· Active not recruiting
- Local Institution - 0402Verified postcodeWest Palm Beach, United States· Active not recruiting
- Local Institution - 0211Verified postcodeAthens, United States· Active not recruiting
- Local Institution - 0048Verified postcodeMarietta, United States· Withdrawn
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects the plasma cells, which are found in the bone marrow and are part of your immune system.
What does 'relapsed or refractory' mean?
Relapsed means the cancer has come back after treatment, and refractory means the cancer hasn't responded to previous treatments.
What is a Phase 3 study?
A Phase 3 study is one of the final steps in testing a new treatment, comparing it to existing treatments to confirm its effectiveness and safety before it can be widely used.
Will I know which treatment I'm getting?
Often in trials like this, participants are assigned to a treatment group by chance, and you may not know which specific treatment you are receiving until the study is over. The study team will explain this to you.
What if I experience side effects?
The study team will closely monitor you for any side effects from the medication. You should always tell your care team about any new or worsening symptoms you experience.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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