A Clinical Phase II, multicenter, Open-label study evaluating iNduction, consolidation and maintenance treatment with Isatuximab (SAR650984), Carfilzomib, LEnalidomide and Dexamethasone (I-KRd) in Primary diagnosed high-risk multiple myeloma paTients _ GMMG-CONCEPT
Multiple myeloma is a type of blood cancer that develops in the bone marrow. Some people have a 'high-risk' form, meaning the cancer may grow faster or be harder to treat with standard therapies. This clinical trial is testing a powerful combination of four medications: isatuximab, carfilzomib, lenalidomide, and dexamethasone (often called I-KRd). Doctors want to find out how well this combination works across different stages of treatment, including initial therapy, intensive treatment, and long-term care to keep the cancer away. The main goal is to see if this treatment can achieve 'minimal residual disease negativity'. This means tests cannot find any remaining myeloma cells, even with very deep, sensitive checks. Researchers will also monitor how long patients stay well without their cancer getting worse, helping doctors understand if this approach offers a better option for high-risk myeloma in the future.
At a glance
What is this study about?
Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell found in the bone marrow. In healthy bodies, plasma cells help fight infections. In myeloma, these cells multiply out of control and crowd out normal blood cells. While treatments have improved over recent years, some people have 'high-risk' myeloma. This means certain genetic features make the cancer more aggressive and more likely to return after standard therapy.
This study, known as GMMG-CONCEPT, tests a modern combination of four targeted medicines: isatuximab, carfilzomib, lenalidomide, and dexamethasone. Together, these drugs attack cancer cells in different ways. Some boost the immune system to fight the cancer, while others block proteins that cancer cells need to grow and survive. The study tracks patients through all phases of care: starting treatment, strengthening the response, and ongoing maintenance to keep the cancer from returning.
The main aim is to clear away as many cancer cells as possible. Doctors use highly sensitive laboratory tests to search for tiny numbers of remaining cancer cells, a state known as minimal residual disease (MRD) negativity. Reaching this deep level of remission often means the cancer stays away for a longer period. By testing this four-drug approach, doctors hope to discover better, more effective ways to help people living with high-risk myeloma.
Key takeaways
- Tests a combination of four drugs for newly diagnosed high-risk multiple myeloma.
- Aims to achieve a very deep level of remission where no cancer cells can be detected.
- Open to adults aged 18 and older with high-risk features.
- Combines oral capsules taken at home with hospital-based intravenous drips.
- Participation is entirely voluntary, and you can withdraw at any point.
Who may be eligible?
This trial is open to adults aged 18 and over who have been newly diagnosed with multiple myeloma. Because the trial specifically looks at harder-to-treat cancer, participants must have 'high-risk' myeloma, which doctors confirm through specialised genetic tests on bone marrow samples.
Both men and women can join. Because the study involves strong medications, participants generally need to be well enough to carry out everyday activities and have adequately working organs, such as the heart, liver, and kidneys.
People who have already had extensive treatment for their myeloma, or those who have other serious, unmanaged medical conditions, may not be able to take part. A hospital specialist team will review each person's medical history in detail to decide if joining is safe.
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.
- I am aged 18 or older.
- I have been newly diagnosed with multiple myeloma.
- My doctor has identified high-risk features in my myeloma cells.
- I have not yet had extensive treatment for my current myeloma.
- I am able to attend regular hospital appointments for tests and drips.
What does participation involve?
Taking part in this study involves several stages of cancer treatment over an extended period, often lasting a few years. You will receive a combination of medicines given in different ways: some are taken as capsules by mouth at home (such as lenalidomide), while others (such as isatuximab and carfilzomib) are given as drips into a vein at a hospital clinic.
You will need to make regular visits to the hospital for treatment, blood tests, and health checks. At certain points, you will have bone marrow tests to see how deeply the cancer has responded. The study doctors will closely monitor your general well-being and any side effects throughout your treatment and during long-term follow-up visits.
Potential risks and benefits
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Common questions
What does 'high-risk' multiple myeloma mean?
It means the myeloma cells have specific genetic changes that make the cancer more likely to grow quickly or return sooner. Doctors use special lab tests to check for these features.
What is 'MRD negativity'?
MRD stands for minimal residual disease. Being MRD-negative means tests cannot detect even one cancer cell in a sample of 100,000 bone marrow cells. It indicates a very deep response to treatment.
Will I have to stay in hospital overnight?
Most treatments, including the intravenous infusions, are given in the outpatient day clinic, so you should usually be able to go home the same day unless you feel unwell.
Can I leave the trial if I find it too difficult?
Yes. Taking part is completely your choice. You are free to stop participating at any point, and your doctor will discuss standard treatment options with you instead.
Do I have to pay for the trial drugs?
No. In the UK, clinical trial medications and study-related tests are provided free of charge to participants.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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