Active not recruitingPHASE2INTERVENTIONAL

Evaluation iNduction, Consolidation and Maintenance Treatment With Isatuximab , Carfilzomib, LEnalidomide and Dexamethasone

This research study is testing a new way to treat multiple myeloma, a type of blood cancer. It's for people who have been recently diagnosed and have a 'high-risk' form of the disease. The study uses a combination of four existing medicines: Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone. These treatments will be given in different stages: an initial treatment to get the disease under control, followed by a 'consolidation' phase, and then a 'maintenance' phase to keep the disease from returning. The main goal is to find out if this combination therapy is safe and works well for patients in a real-world setting, as it's the first time these specific drugs have been tried together in this way for high-risk patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

246

Start

15 Aug 2017

Estimated completion

01 Sep 2026

Multiple Myeloma

What is this study about?

This study is looking into a new treatment plan for a type of blood cancer called multiple myeloma. This cancer affects certain cells in your bone marrow. The study is particularly for people who have been recently diagnosed and whose myeloma is considered 'high-risk,' meaning it might be more difficult to treat or more likely to come back.

The treatment involves a combination of four different medicines: Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone. These drugs work in different ways to fight cancer cells. Researchers are giving these medicines in a step-by-step approach: first, an 'induction' phase to reduce the cancer, then a 'consolidation' phase to further control it, and finally a 'maintenance' phase to keep it from growing again. The idea is to see if using these four drugs together in this specific way can provide a better outcome for patients with high-risk multiple myeloma.

By taking part, you would be helping doctors understand if this new combination of treatments is safe and effective. This type of research helps improve future care for many people with multiple myeloma. It’s important to remember that this is a research study, and while the hope is for positive results, there are no guarantees.

Key takeaways

This study is for newly diagnosed, high-risk multiple myeloma.
It tests a new combination of four existing cancer drugs.
Treatment is given in stages: induction, consolidation, and maintenance.
The goal is to see if this combination is safe and effective.
You'll have regular hospital visits for monitoring and tests.
It's a Phase 2 study, meaning it's exploring effectiveness and safety in more detail.

Who may be eligible?

To join this study, you must have been recently diagnosed with multiple myeloma that is causing symptoms, and your doctor must confirm it is 'high-risk.' This means certain genetic changes are present in your cancer cells, or your disease is at a specific stage.

You also need to have clear signs of the disease that doctors can measure, such as a certain level of M-protein in your blood or urine. If your myeloma is a very rare type that doesn't produce much M-protein, there are other specific ways doctors would check to see if you can join.

Importantly, you must be at least 18 years old and generally well enough to take part, with a good level of activity in your daily life. If you are a woman who could become pregnant, you would need to use reliable birth control during the study and for a period afterwards.

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 been recently diagnosed with multiple myeloma?
Has my doctor said my myeloma is 'high-risk'?
Am I at least 18 years old?
Do I have clear signs of myeloma that doctors can measure?
Am I generally well enough for daily activities?
If I can become pregnant, am I able to use reliable contraception?
Can I attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the four study drugs: Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone. These will be given to you in stages: an initial treatment, followed by a strengthening phase, and then a longer-term maintenance treatment. The study involves regular visits to the hospital or clinic so that the study team can monitor your health and the effects of the treatment. This will include blood tests, urine tests, and other checks to see how well the treatment is working and to look out for any side effects. The exact number of visits and tests will be explained to you by the study team, but you should expect to be in regular contact with them throughout your participation. The total duration of your involvement in the study will depend on how you respond to the treatment and the study plan, but some parts of the treatment, like maintenance, can last for a long time.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit from receiving a new treatment combination that could be more effective for your high-risk multiple myeloma than standard options. However, this is not guaranteed, as it is a research study. There are also risks involved, as with any medication. The drugs used may cause side effects, which can vary from mild to severe, and the study team will monitor you closely for these. You will be given full details of known side effects before you decide to join. It is very important to remember that participating is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Vivantes Am Urban
Verified postcode
Berlin, Germany
Campus Benjamin Franklin Charite Berlin
Verified postcode
Berlin, Germany
Vivantes Klinikum Neukölln
Verified postcode
Berlin, Germany
Städt. Kliniken Bielefeld Klinikum Mitte
Verified postcode
Bielefeld, Germany
Johanniter-Krankenhaus Bonn
Verified postcode
Bonn, Germany
Uniklinikum Chemnitz
Verified postcode
Chemnitz, Germany
Uniklinik Köln
Verified postcode
Cologne, Germany
St. Antonius Hospital
Verified postcode
Eschweiler, Germany
Universitätsklinikum Essen
Verified postcode
Essen, Germany
Asklepios Altona
Verified postcode
Hamburg, Germany
University Hospital Hamburg Eppendorf
Verified postcode
Hamburg, Germany
University Hospital Heidelberg
Verified postcode
Heidelberg, Germany

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, which are a type of white blood cell found in your bone marrow. These cells normally help fight infections. In multiple myeloma, they grow abnormally and can cause problems in your bones, kidneys, and blood.

What does 'high-risk' multiple myeloma mean?

High-risk multiple myeloma means that your cancer has certain features, like specific genetic changes or advanced stage, which suggest it might be more challenging to treat or could return more quickly than other types of myeloma. This study is specifically for people with this type.

Are the study drugs new or already approved?

The four drugs being used (Isatuximab, Carfilzomib, Lenalidomide, Dexamethasone) are already approved for treating multiple myeloma. What's new is testing them all together in this specific combination and treatment plan, especially for people with high-risk disease.

Will I receive a placebo (dummy treatment)?

No, this study is 'open-label,' which means everyone in the study will receive the active study drugs. There is no placebo group in this particular trial.

How long will I be on treatment if I join?

The treatment is given in different phases: an initial phase, then a consolidation phase, and finally a maintenance phase. The maintenance phase can last for a prolonged period, guided by your response and the study plan. The study team will explain the expected timeline in detail.