Have you tried several treatments for your multiple myeloma? A clinical research study may be an option for you.

Each day we learn more about relapsed/refractory multiple myeloma, and researchers continue to work on ways to treat it. This study is researching a potential treatment for multiple myeloma in people for whom at least three types of treatment have not been effective.

Who may participate

Participating in a clinical research study is an important and personal decision. Thank you for considering the MagnetisMM-3 study.

This study is looking for about 150 participants with relapsed/refractory multiple myeloma. Among other things, participants must have tried, but not had success with, each of the following treatments:

  • At least 1 IMiD (immunomodulatory drug), such as lenalidomide or pomalidomide
  • At least 1 PI (proteasome inhibitor), such as bortezomib and carfilzomib
  • At least 1 anti-CD38 mAB (monoclonal antibody), 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, with 1-2 visits to the study location. Reasonable travel arrangements, including hotel accommodations and ground transportation may be covered.  Please discuss this with the site staff for details.

Condition
Relapsed / refractory multiple myeloma

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age
18+ years

The age a person must be to participate in a clinical trial.

Sex
Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

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.

 

See if you may qualify

 

What to expect

If you’ve met all eligibility criteria, the study treatment period begins. You will stay in the hospital for the first and second dose of the study medicine so that your health can be monitored by the study team. Everyone who takes part in the study will receive the study medicine (there is no placebo).

For the next 6 months, you will see the study doctor and receive the study medicine at weekly visits. The study team will perform physical exams and other tests to monitor your health. After the initial 6 months, the dosing schedule may be adjusted. If the study doctor sees that your multiple myeloma has progressed or if you experience any side effects that are difficult to manage, the study medicine will be discontinued.

Approximately one month after the last dose of study medicine, there will be a final visit so the study team can observe your health. Following the last visit, the study team will contact you by phone (or you may have a visit) about once every three months to check on your health.

Length of treatment
Up to 2+ years

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits
Up to 53 in the first year

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up
1 call or visit every 3 months

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time.

About the study medicine

We are studying if this study medicine, elranatamab, is safe and effective for people who have tried at least three other unsuccessful types of treatments for their multiple myeloma.

Elranatamab is given as a subcutaneous injection—that is, a shot under the skin, rather than an IV infusion. Elranatamab will be administered by a trained medical professional.

What are the benefits and risks of taking part in the MagnetisMM-3 study?

People who take part in clinical trials are key to advancing medical research. By taking part in the MagnetisMM-3 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, 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

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.

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How does this study medicine work?

We believe the study medicine could work by binding to T-cells (a type of cell in the immune system) and to myeloma cells (cancer cells), potentially causing the immune cells to kill the cancer cells.

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How do current treatment options for multiple myeloma work?

  • IMiDs help adjust the immune response 
  • Anti-CD38 mABs kill cancer cells and activate other cells to fight infection 
  • PIs alter the messages your body sends to your cells   
  • BCMA antibodies target a protein found on the surface of myeloma cells 
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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.

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Will I have to pay to be in the study? Will my insurance cover the cost?

The study medicine and all study-related medical 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. 

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Is there travel support available for participants in this study?

Reasonable travel arrangements, including hotel accommodations and ground transportation, may be covered. Please discuss the details with your study team.

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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.

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What will happen to my personal information after the study ends?

Some of the information collected on devices will be kept for up to 25 years. All other records will be deleted after 15 years.

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