GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
This research study is for people recently diagnosed with multiple myeloma, a cancer of the plasma cells in the bone marrow. The main goal is to find out how safe and effective several new drug combinations are. Some of these combinations, which include drugs like teclistamab, talquetamab, and JNJ-79635322, could potentially be used as part of initial treatment or as ongoing maintenance. A key part of the study is exploring whether some new treatments could offer an alternative to a high-dose chemotherapy and stem cell transplant, which is a standard treatment for some patients. Researchers will carefully watch participants to understand how well these new drug combinations work and if they cause any side effects.
At a glance
What is this study about?
This study is about finding better ways to treat multiple myeloma, a cancer that affects certain white blood cells called plasma cells. These cells, found in your bone marrow, help your body fight infections. When you have multiple myeloma, these cells grow too much and can cause problems in your bones, kidneys, and immune system.
The researchers are testing different combinations of new medicines, including ones called teclistamab, talquetamab, and JNJ-79635322. These drugs fight cancer in specific ways. The study wants to see how well these new combinations work at shrinking the cancer and if they are safe for people to take. Some parts of the study are also looking into whether these new treatments could replace a procedure known as a stem cell transplant, which is currently a common treatment for certain patients.
By taking part, individuals could help doctors learn more about these new treatments. This knowledge is important for potentially developing more effective and perhaps easier treatment options for people with newly diagnosed multiple myeloma in the future.
Key takeaways
- This study evaluates new drug combinations for newly diagnosed multiple myeloma.
- It aims to assess safety and effectiveness of treatments like teclistamab and talquetamab.
- Some parts explore alternatives to a stem cell transplant.
- Participants will receive treatment for up to two years, with ongoing monitoring.
- The goal is to find better treatment options for the future.
Who may be eligible?
This study is looking for people between 18 and 70 years old who have recently been diagnosed with multiple myeloma and need treatment. You'll need to be generally well enough to take part in a study like this, which doctors often describe using a score for your daily activity level. You'll also need to have clear signs of multiple myeloma that doctors can measure.
If you've already had some initial treatment for your multiple myeloma and a stem cell transplant, there are specific parts of the study you might be able to join. For these groups, you would have completed your initial treatment and transplant within a certain timeframe and be responding well to treatment.
However, you wouldn't be able to join if your multiple myeloma has spread to your brain or spinal cord. The study also has certain requirements about your overall health and other medical conditions.
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.
- Are you between 18 and 70 years old?
- Have you been recently diagnosed with multiple myeloma?
- Are you generally well enough to participate in a study?
- Do you have measurable signs of multiple myeloma?
- Is your Multiple Myeloma NOT affecting your brain or spine?
What does participation involve?
If you join this study, you'll be one of about 160 participants. Depending on the treatment group you're in, you might receive a combination of medicines like Teclistamab, Talquetamab, or JNJ-79635322 along with other standard drugs like Daratumumab, Dexamethasone, Lenalidomide, or Bortezomib. For many, this will involve six cycles of initial treatment (called 'induction') over about six months, with each cycle lasting 28 days. After this, some participants will have a standard stem cell transplant, followed by up to 18 cycles of maintenance treatment.
Other groups might receive treatments that aim to replace the need for a stem cell transplant. For these groups, the treatment would also last up to 18 cycles after the initial induction phase. You'll have regular check-ups to monitor your health, how the treatment is working, and any side effects. You'll continue in the study until your disease gets worse, you experience side effects that are too difficult to manage, or until the end of the study. There will also be follow-up appointments after you stop treatment to continue checking on your health.
Potential risks and benefits
Locations (11)
- Charité University Medicin BerlinVerified postcodeBerlin, Germany· Recruiting
- Clinic Chemnitz gGmbHVerified postcodeChemnitz, Germany· Recruiting
- University Clinic Technical University DresdenVerified postcodeDresden, Germany· Recruiting
- University Clinic DüsseldorfVerified postcodeDüsseldorf, Germany· Recruiting
- University Clinic FreiburgVerified postcodeFreiburg im Breisgau, Germany· Recruiting
- Hamburg University Clinic EppendorfVerified postcodeHamburg, Germany· Recruiting
- Asklepios Clinic Hamburg AltonaVerified postcodeHamburg, Germany· Recruiting
- University Hospital HeidelbergVerified postcodeHeidelberg, Germany· Recruiting
- University Clinic Schleswig-Holstein Campus KielVerified postcodeKiel, Germany· Recruiting
- Technical University MunichVerified postcodeMunich, Germany· Recruiting
- University WürzburgVerified postcodeWürzburg, Germany· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects specific white blood cells (plasma cells) in your bone marrow. These cells normally help fight infections but can grow too much and cause problems.
What are the new drugs being tested?
The study is looking at several new drugs like teclistamab, talquetamab, and JNJ-79635322, often in combination with other standard multiple myeloma medicines.
Why are they doing this study?
Researchers want to find out if these new drug combinations are safe and effective for people with newly diagnosed multiple myeloma, and if some could offer alternatives to stem cell transplants.
Will I have a stem cell transplant if I join?
It depends on which part of the study you're in. Some groups will have a stem cell transplant, while others will receive treatments that explore alternatives to it.
How long does the study last?
The treatment part of the study can last for many months, up to about two years, followed by regular follow-up checks for a longer period.
How to find out more
Marc S Raab, Prof. Dr. med
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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