If you have been newly diagnosed with multiple myeloma and are not eligible for stem cell transplantation , this study may be a good fit
The MagnetisMM-6 study is researching a study medicine (elranatamab) in combination with two standard multiple myeloma treatments (daratumumab and lenalidomide).
The goal of this study is to learn about the effects of the elranatamab combination compared to a combination of only standard treatments, to establish whether the elranatamab combination may better treat multiple myeloma
Who may participate
Participating in a clinical study is an important and personal decision. We are currently looking for people to join Part 2 of the MagnetisMM-6 study.
Part 2 of the MagnetisMM-6 study may be an option for people who are 18 years or older and:
- Have been newly diagnosed with multiple myeloma
- Are not eligible for a stem cell transplant
There are other requirements for participation in Part 2 of the MagnetisMM-6 study. The study doctor can explain these to you.
Condition
Multiple myeloma
Age
18+ years
Sex
Male or female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Additional eligibility criteria
Part 2 of the MagnetisMM-6 study may be an option for people who are 18 years or older and:
You may not qualify for the study if you:
What to expect
If Part 2 of this study is a good fit for you and you choose to take part, you will be randomly assigned with a 50% (1 in 2) chance to ‘Arm A’ or ‘Arm B’:
- Arm A - You will receive elranatamab + daratumumab + lenalidomide (referred to as EDR)
- Arm B - You will receive daratumumab + bortezomib + lenalidomide + dexamethasone (referred to as D-VRd)
This is an open-label study, which means that you and your study doctor will know which treatment arm you will be assigned to.
The study team will perform tests and assessments throughout the study to monitor your health and safety as well as the effectiveness of the study medicine.
About a month after the last dose of your study treatment or decision to stop study treatment (whichever is later), there will be a visit to allow the study team to observe your health and safety. You will then continue to have phone calls or visits about every one to three months so the study team can check on your health.
Length of study treatment
Depends how long you receive the study medicine
Number of study visits
Up to four visits over each 28-day cycle
Long-term follow up
One call or visit about every one to three months
About the study medicine
The study medicine, elranatamab, is thought to work as a bispecific antibody.
Bispecific antibodies differ to monoclonal antibodies as they can attach to two different types of cells rather than one.
Bispecific antibodies are currently being researched by scientists as potentially effective treatments for different diseases, especially cancers.
Bispecific antibodies with one part that binds to a cancer cell and one part that binds to an immune system cell may cause the immune system to attack and destroy the cancer cell.
Elranatamab, the study medicine in this trial, is thought to work by connecting T-cells (certain immune system cells) to myeloma cells (cancer cells).
Connecting these cells may activate the immune cells, potentially destroying the myeloma cells.
Frequently asked questions
Multiple myeloma is a type of blood cancer that forms in bone marrow. Healthy bone marrow produces plasma cells, which make antibodies to fight infection. But in multiple myeloma, plasma cells become cancerous. These cancer cells can crowd out normal blood cells, forming tumors and leaving a person vulnerable to infection.
The study drug is thought to work by connecting certain immune system cells, known as T-cells, to myeloma cells (cancer cells). Connecting these cells activates the immune cells, potentially killing the myeloma cells.
Informed consent is one of the most important tools to help you understand how your rights, safety, and well-being will be addressed throughout the trial.
During the informed consent discussion, you will be given all details about the trial, including potential benefits and risks of taking part. You will also be given a document summarizing this information, which you will sign to confirm that you would like to take part in the clinical trial.
Yes, participation in clinical trials is completely voluntary: taking part in a trial is your choice. You are free to stop being in this trial at any time and for any reason and it will not affect your future medical care in any way.
Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical trials also help us learn more about any side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.
The study medicine, approved medicines, and all study-related care and procedures are provided at no cost. You don’t need health insurance to join this clinical trial. However, you (or your health insurance provider) may be responsible for medical expenses that are part of your usual healthcare. Talk with your study team or review the informed consent document to find out exactly what is covered.
Travel to the study site and other expenses (such as meals) may be covered. Please discuss the details with your study team.
Your health information and any data that could be used to identify you (such as immigration status) will be kept private and safe. Only information that relates to the study will be collected, and only your study team, study doctor, and organizations that oversee the study will be able to access it. Your personal information won’t be shared with third parties such as the government or advertisers.
Some of the information collected on devices will be kept for up to 25 years. All other records will be deleted after 15 years.
