A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
This research study is looking at a new treatment called ramantamig for people in the UK who have recently been diagnosed with multiple myeloma. Multiple myeloma is a type of blood cancer. This study is specifically for those who won't be having a stem cell transplant as their first treatment. The main goal is to see if adding ramantamig to standard treatments (Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone, or just Daratumumab, Lenalidomide, and Dexamethasone) can stop the cancer from getting worse for longer, and if it can help more people achieve a full response where cancer cells are not found. It's a Phase 3 study, meaning it's comparing the new treatment against established ones.
At a glance
What is this study about?
This study is for adults recently diagnosed with multiple myeloma, a type of blood cancer that affects white blood cells called plasma cells. Researchers want to find better ways to treat this condition, especially for people who are not planning to have a stem cell transplant as their first treatment. This might be because of their age, other health conditions, or personal choice.
The study aims to compare a new medicine, called ramantamig, when given alongside existing treatments, against those standard treatments alone. The standard treatments are combinations of medicines like Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (sometimes called DVRd or DRd). The main things the study will check are how long people stay well without their cancer getting worse, and how many people have a very good response to the treatment, meaning no cancer cells can be found after 12 months.
By taking part, you could help doctors understand if this new combination treatment is more effective than current options. This information could lead to new ways of treating multiple myeloma in the future, benefiting many patients. It's a big step in research to improve care for this blood cancer.
Key takeaways
- This study is for newly diagnosed multiple myeloma patients not having a stem cell transplant.
- It tests a new medicine called ramantamig alongside standard treatments.
- The goal is to see if the new combination stops cancer from worsening for longer.
- It also checks if more patients achieve a 'complete response' where no cancer cells are found.
- Your participation could help improve future treatments for this blood cancer.
Who may be eligible?
To join this study, you must have been recently diagnosed with multiple myeloma and it must be confirmed by specific medical tests. You also need to be someone who won't be having a stem cell transplant as your very first treatment. This could be because of your age, other health issues that make a transplant risky, or if you and your doctor decide to delay a transplant.
Doctors will also check your general health and how well you can do daily activities. You'll need to be well enough to take part. Your cancer must also be measurable, meaning doctors can track its progress with tests.
There are also some reasons you might not be able to join. For example, if you've already had treatment for multiple myeloma (apart from short-term steroids for emergencies), if you have a known allergy to any of the study medicines, or if your myeloma has spread to your brain or spinal cord. If you've had major surgery recently or have other serious health problems, you might not be able to join either.
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.
- Have I recently been diagnosed with multiple myeloma?
- Am I NOT planning to have a stem cell transplant as my first treatment?
- Am I generally well enough for a clinical study?
- Do I have any known severe allergies to medicines?
- Have I had any previous treatments for multiple myeloma (other than emergency steroids)?
- Is my multiple myeloma affecting my brain or spinal cord?
What does participation involve?
If you join this study, you'll receive either the new treatment combination (ramantamig plus standard drugs) or one of the standard treatment combinations. You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. These visits will help doctors monitor your health and how you're responding to the treatment. You'll also have specific tests to check for cancer cells at different times.
The study will involve taking the medication as prescribed, attending all scheduled appointments, and reporting any side effects or changes in your health to the study team. The total duration of your participation in the study, including treatment and follow-up checks, will be explained by the study team. It's important to understand that you can decide to stop participating at any time.
Potential risks and benefits
Locations (30)
- CHU NantesVerified postcodeNantes, France· Recruiting
- CHU Lyon SudVerified postcodePierre-Bénite, France· Recruiting
- Evangelismos S AVerified postcodeAthens, Greece· Recruiting
- Alexandra General Hospital of AthensVerified postcodeAthens, Greece· Recruiting
- Rambam Med.Center - Hematology InstituteVerified postcodeHaifa, Israel· Recruiting
- Carmel Medical CenterVerified postcodeHaifa, Israel· Recruiting
- Shaare Zedek Medical CenterVerified postcodeJerusalem, Israel· Recruiting
- Rabin Medical CenterVerified postcodePetah Tikva, Israel· Recruiting
- Sheba Medical CenterVerified postcodeRamat Gan, Israel· Recruiting
- Tel Aviv Sourasky Medical CenterVerified postcodeTel Aviv, Israel· Recruiting
- Sint Antonius ZiekenhuisVerified postcodeNieuwegein, Netherlands· Recruiting
- Pratia Onkologia KatowiceVerified postcodeKatowice, Poland· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in the plasma cells, which are a kind of white blood cell found in your bone marrow. These cells help fight infection, but in myeloma, they grow out of control.
What is a 'stem cell transplant' and why might I not be having one?
A stem cell transplant is an intensive treatment that replaces damaged bone marrow with healthy cells. Some people don't have one because of their age, other health problems, or they might choose to have other treatments first.
What does 'progression-free survival' mean?
This is how long a person lives with the disease without it getting worse or spreading. It's a way for doctors to measure how well a treatment is working.
What does 'MRD-negative complete response' mean?
This means that after treatment, doctors can't find any cancer cells in your body using very sensitive tests. It's a very good sign that the treatment has been effective.
Will I know which treatment I'm getting?
This is a 'blinded' study, meaning you might not know whether you're getting the new treatment combination or a standard one. This helps ensure the results are fair and accurate.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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