Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
This research study is for people recently diagnosed with multiple myeloma who haven't started treatment yet. It's investigating if adding a new drug called Isatuximab can improve how well standard treatment works. The study is split into two main parts. In the first part, some patients will receive standard initial treatment, while others will get standard treatment plus Isatuximab. After an intensive treatment phase, there's a second part where patients receive maintenance therapy. Again, some will get standard maintenance, and others will get standard maintenance plus Isatuximab. Researchers want to compare the effectiveness of these different approaches, particularly looking at how much myeloma disease remains and how long patients stay free from their disease progressing.
At a glance
What is this study about?
If you've recently been diagnosed with multiple myeloma and are looking into treatment options, this research study might be relevant to you. Doctors are always looking for better ways to treat multiple myeloma, and this study is testing if a new drug, Isatuximab, can improve the effectiveness of current standard treatments.
The study is designed in two main stages. Initially, patients will receive a combination of standard drugs (Lenalidomide, Bortezomib, and Dexamethasone). Some patients will also receive Isatuximab alongside these standard drugs. This first stage aims to see if adding Isatuximab helps reduce the amount of myeloma cells more effectively right from the start. After this initial treatment, you'd typically go through a process to collect your stem cells for a possible stem cell transplant, which is a common part of intense myeloma treatment.
The second stage of the study happens after this initial intensive phase. Here, patients will receive a maintenance treatment, which is a long-term therapy designed to keep the myeloma under control. Again, some patients will receive standard maintenance therapy, while others will receive standard maintenance therapy plus Isatuximab. The main goal here is to see if adding Isatuximab can help keep the disease from returning or getting worse for a longer period.
Key takeaways
- This study evaluates adding Isatuximab to standard myeloma treatment.
- It has two phases: initial treatment and long-term maintenance.
- The goal is to see if Isatuximab improves treatment success and extends disease control.
- Participation lasts about 3.5 to 4 years with regular check-ups.
- It's for newly diagnosed multiple myeloma patients aged 18-70.
- Treatment groups are chosen randomly, not by patient choice.
Who may be eligible?
This study is for adults generally between 18 and 70 years old who have been newly diagnosed with multiple myeloma and haven't started treatment yet. You'd also need to be well enough to undergo intensive treatment, including a potential stem cell transplant.
To be considered for this study, doctors need to be able to measure your myeloma cells in your blood or urine. This helps them track how well the treatment is working. Women who could become pregnant would need to have a negative pregnancy test and agree to use effective birth control throughout the study, as would men whose partners could become pregnant. This is because some study medications can be harmful to an unborn baby.
There are also certain situations that would prevent someone from joining the study. For example, if you have a known allergy to any of the medicines used in the study, or if you have certain other medical conditions, you might not be able to participate. The study team will review all your medical information carefully to see if it's a good fit for you.
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 and haven't started treatment yet?
- Are you generally well enough to undergo intensive treatments?
- Can doctors measure your myeloma levels in your blood or urine?
- If you are a woman who could become pregnant, are you willing to use birth control and have a negative pregnancy test?
- Do you have any known severe allergies to common medications used in cancer treatment?
What does participation involve?
If you decide to join this study, your journey will involve several steps over about 3.5 to 4 years. Initially, you'll go through 3 cycles of 'induction' treatment, which involves taking a combination of medicines. Some people will receive an extra medicine, Isatuximab, during this phase. Each cycle lasts 42 days. Following this, you'll likely have an intensive treatment phase, which usually includes preparing for and potentially having a stem cell transplant. There will then be a break of about three months.
After this break, you'll start a 'maintenance' treatment phase, which will last for three years. Again, some people will take an additional medicine, Isatuximab, during this time. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. All study medications will be provided. You can withdraw from the study at any time.
Potential risks and benefits
Locations (72)
- Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und StammzelltransplantationVerified postcodeAachen, Germany
- Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und PalliativmedizinVerified postcodeBad Saarow, Germany
- Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (Hämatologie/Onkologie)Verified postcodeBerlin, Germany
- Vivantes Klinikum Neukölln, Klinik für Hämatologie und OnkologieVerified postcodeBerlin, Germany
- HELIOS Klinikum, Klinik für Hämatologie, Onkologie und ImmunologieVerified postcodeBerlin, Germany
- Studiengesellschaft Onkologie Bielefeld GbRVerified postcodeBielefeld, Germany
- Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und PalliativmedizinVerified postcodeBielefeld, Germany
- Medizinische Universitätsklinik, KnappschaftskrankenhausVerified postcodeBochum, Germany
- Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und RheumatologieVerified postcodeBonn, Germany
- Johanniter Krankenhaus BonnVerified postcodeBonn, Germany
- Zentrum für ambulante Hämatologie und Onkologie (ZAHO)Verified postcodeBonn, Germany
- Städtisches Klinikum Braunschweig, Med. Klinik III, Hämatologie und OnkologieVerified postcodeBraunschweig, Germany
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the 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 is Isatuximab?
Isatuximab is a new type of drug called a monoclonal antibody. It works by targeting specific proteins on myeloma cells, helping your immune system to find and destroy them.
What does 'induction therapy' mean?
Induction therapy is the first main treatment you receive for your multiple myeloma. It's designed to reduce the number of cancer cells in your body as much as possible before other treatments, like a stem cell transplant.
What is 'maintenance therapy'?
Maintenance therapy is a longer-term treatment given after initial intense treatments. Its purpose is to keep the remaining cancer cells under control and try to prevent the disease from coming back or getting worse.
Can I choose which treatment arm I'm in?
No, you don't get to choose. You'll be randomly assigned to one of the treatment groups, like flipping a coin. This helps make sure the study results are fair and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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