Despite recent progress in treatment of multiple myeloma, additional treatment options are still needed.
We’re hoping to learn more about a study medicine called elranatamab to better understand if it could potentially help treat relapsed/refractory multiple myeloma.
Who may participate
Participating in a clinical study is an important and personal decision. Thank you for considering the MagnetisMM-9 study.
This study is looking for about 76 participants with relapsed/refractory multiple myeloma. Among other things, participants in this study must have tried but not had success with their most recent multiple myeloma therapy and at least one of each of the following treatments:
- Proteasome inhibitor (PI), such as bortezomib or carfilzomib
- Immunomodulatory drug (IMiD), such as lenalidomide or pomalidomide
- Anti-CD38 monoclonal antibody (mAb), such as daratumumab or isatuximab
If you are not sure which treatments you have received, please ask your doctor.
If you’re interested in participating, you will review and sign the informed consent document and continue with the screening process to confirm whether you’ve met all eligibility criteria. The screening period will take up to 28 days including at least 1 visit to the study location.
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
The treatment period for this study begins after the screening visit. You will stay in the hospital two to three times throughout this period so that your health can be monitored by the study team.
For the first six months, you will be asked to see the study doctor every week or every other week to receive injections of the study medicine and complete various health assessments. After six months, your study treatment schedule may be adjusted.
As a participant in this study, you will receive the study medicine until your multiple myeloma progresses, you experience side effects that are hard to manage, or you choose to stop receiving the study medicine.
Approximately one month after the last dose of study medicine, there will be one follow-up visit so the study team can observe your health and safety. Then, the study team will contact you by phone about once every three months (or you may have a visit) to check on your health.
The total length of treatment will vary depending on how you tolerate and how your disease responds to the study medicine. Even if you stop taking the study medicine, you will be asked to stay in the study for at least two years.
1 phone call every 3 months
Some studies require the study team to stay in contact with the participant for a period of time after the main part of the study is completed. This long-term follow up is to collect additional information on your health and the study medicine over time.
About the study medicine
We are researching the safety and effectiveness of the study medicine elranatamab in people who have tried but not had success with their most recent multiple myeloma therapy or treatments from three different drug classes. The study medicine is a type of treatment called a B-cell maturation antigen (BCMA) and it will be given to all participants as a shot given under the skin (called a subcutaneous injection), not through an IV.
We believe it could work by binding to T-cells (a type of cell in the immune system) to myeloma cells (cancer cells), potentially causing the immune cells to kill the cancer cells. No placebo is used in MagnetisMM-9.
What are the benefits and risks of taking part in the MagnetisMM-9 study?
People who take part in clinical trials are key to advancing medical research. By participating in the MagnetisMM-9 study you will be aiding medical research, which may help others with multiple myeloma in the future.
Over the course of the study, your health may get better, worse, or stay the same. If you consider taking part in the study you will be given a complete list of risks and possible discomforts before agreeing to participate. As with any therapy, there may be a reaction to the study medicine.
Frequently asked questions
What is multiple myeloma?
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.
How do current treatment options for multiple myeloma work?
- Immunomodulatory imide drugs (IMiDs) help adjust the immune response
- Anti-CD38 mAbs kill cancer cells and activate other cells to fight infection
- Proteasome inhibitors (PIs) alter the messages your body sends to your cells
- BCMA antibodies target a protein found on the surface of myeloma cells
What do relapse and refractory mean?
RELAPSE is when a treatment works for a while and then stops. REFRACTORY is when a disease doesn’t respond to treatment. Relapsed/refractory multiple myeloma refers to multiple myeloma that either comes back after responding to treatment or doesn’t respond to treatment at all.
Will I have to pay to be in the study? Will my insurance cover the cost?
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.
Is there travel support available for participants in this study?
Travel to the study clinic and other expenses (such as meals) may be covered. Please discuss the details with your study team.
Will my personal information be kept private?
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.
What will happen to my personal information after the study ends?
All records and documents pertaining to the study will be kept for up to 15 years. Banked samples will be stored indefinitely.
