We invite you to learn more about MagnetisMM-32, a clinical trial to explore a potential treatment option for people with multiple myeloma
MagnetisMM-32 is a Phase 3 study looking for around 500 participants with multiple myeloma that has come back after prior treatment. The study is designed to compare the study medicine (elranatamab) alone versus several other medicines given together (combination treatment). There is no placebo (inactive medicine) in this study, and all participants will receive active treatment.
Thank you for taking the time to find out more information about this study.
Who may participate
This study may be an option for men and women who:
- Are at least 18 years old
- Have multiple myeloma that has come back after prior treatment (at least 1 but not more than 4 rounds of treatment)
- Have had prior treatment with certain therapies (the study team can explain what these are)
There are other requirements for taking part in this study. The study team can explain these to you if you’d like to learn more.
People of all backgrounds can be diagnosed with multiple myeloma, but it is more likely to develop in people of races and ethnicities often underrepresented in clinical trials. By participating in MagnetisMM-32, you will play an important role in helping to represent your community and in helping us understand how treatments work across different race, ethnicities, ages, and sexes.
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.
What to expect
Participants will be randomly (by chance) assigned to one of two treatment ‘Arms’.
Arm A will receive the study medicine (elranatamab) as a shot under the skin and will have 2 study visits in the first week (including an overnight hospitalization), followed by about 1 study visit each week. The visit frequency may be reduced later in the study.
Arm B will receive a combination treatment (selected by the study doctor), which includes medicines given as a shot under the skin or needle into the vein and medicines taken by mouth. Arm B will have study visits about once every week, but the actual number of visits will depend on the selected combination treatment.
The study team will assess your health, safety and the effects of the study medicine.
After a final visit about a month after your last dose, you will have clinic visits or phone calls about every 1 to 3 months to check on your health.
Length of study treatment
Depends on how well you respond to study treatment, but could last up to about 5 years.
Number of study visits
1-6 visits per month, until the end of study treatment
Long-term follow up
1 call or visit about every 1 to 3 months
Watch a short video about the MagnetisMM-32 study
Potential benefits and risks of taking part in the MagnetisMM-32 study
People who take part in clinical studies are key to advancing medical research. By taking part in the MagnetisMM-32 study, you will be aiding medical research which may help others with multiple myeloma in the future.
Over the course of the study, a participant’s health may get better, get worse, or stay the same. People who are considering taking part in the study will be given a complete list of risks and possible discomforts before agreeing to participate. As with any medication, there may be a reaction to the study medicine.
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 medicine 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 study, 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 research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.
Phase 3 clinical trials test the safety and effectiveness of the study medicine. Phase 3 is the last phase of testing to be completed before the study medicine is submitted for regulatory review and potential approval.
If you are randomly assigned to receive combination treatment, you will receive one of the following combinations (based on your study doctor’s decision):
- elotuzumab + pomalidomide + dexamethasone (called “EPd”)
- pomalidomide + bortezomib + dexamethasone (called “PVd”)
- carfilzomib + dexamethasone (called “Kd”)
The study medicine and all study-related care and procedures are provided at no cost. You don’t need health insurance to join a clinical study. 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 center 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.
