A clinical trial to assess a potential treatment option for multiple myeloma
The MagnetisMM-7 study is a phase 3 clinical trial looking for around 660 participants with newly diagnosed multiple myeloma following autologous stem cell transplant (ASCT). The study is designed to assess whether the study medicine can provide clinical benefit when compared to the current standard of care therapy.
Who may participate
Participating in a clinical study is an important and personal decision. Thank you for considering the MagnetisMM-7 study.
This study may be an option for men and women who:
- Are at least 18 years old
- Have newly diagnosed multiple myeloma after undergoing ASCT
- Have not had previous maintenance treatment for multiple myeloma
There are other requirements for taking part in this study. We will explain these to you if you’d like to learn more.
If you’re interested in participating, you will review and sign an informed consent document and visit the study doctor’s office during a screening process to see whether you meet the eligibility criteria and are able to take part.
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 B will take the comparator medicine as oral capsules every day and will have 1 visit every 1 or 2 weeks for 3 months, followed by 1 visit every 4 weeks.
Arm C will receive the investigational medicine at hospital as an injection under the skin and have visits fortnightly for 7-18 months (depending on how their disease responds to the study treatment), then every 4 weeks. Overnight hospitalization is required for the first injection and possibly the second.
The study team will assess your health, safety and the effectiveness of the study medicines. Participants who stop taking the study medicine will be asked to continue attending monthly visits to assess their cancer.
After a final visit about a month after your last dose (or last monthly visit), you will have phone calls every 3 months or clinic visits every month until disease progression, to check on your health. More follow-up visits may be required, depending on your disease.
Length of study treatment
Depending on the number of cycles, this could last approximately 7 years
Number of study visits
1-4 visits per 28-day cycle, until end of study treatment
Long-term follow up
1 call or visit at least every 3 months
About the study medicine
We are studying if elranatamab (the study medicine) is safe and effective for people newly diagnosed with multiple myeloma after undergoing autologous stem-cell transplantation (ASCT).
Elranatamab is given as a shot under the skin (subcutaneous injection) – not through an IV infusion (via a drip) – and is administered by a trained medical professional.
Potential benefits and risks of taking part in the MagnetisMM-7 study
People who take part in clinical studies are key to advancing medical research. By taking part in the MagnetisMM-7 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.
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.
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.
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.
