NCT05090566

Each day we learn more about relapsed/refractory multiple myeloma and researchers continue to work on ways to treat it. If you have tried prior treatments for your multiple myeloma the MagnetisMM-4 study may be an option for you.

MagnetisMM-4 is researching if the study medicine elranatamab can be both safe and effective when given in combination with other anti-cancer medicines in people with multiple myeloma. To learn more about the study design, please read the section titled “About the MagnetisMM-4 sub-studies”.

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Who may participate

Participating in a clinical trial is an important and personal decision. Thank you for considering the MagnetisMM-4 study.

MagnetisMM-4 has multiple sub-studies.  Each sub-study will have its own unique requirements for who may participate. Before you can participate in a clinical trial you will review and sign the informed consent document. If you choose to sign the document, you will continue to the screening period to confirm whether you meet all eligibility criteria and are able to continue participation. 

The screening period will take up to 28 days, with 2-3 visits to the study clinic. Reasonable travel arrangements, including hotel accommodations and ground transportation may be covered.  Please discuss this with the study staff for details.

Condition

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.

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What to expect

If you’ve met all eligibility criteria you will stay in the hospital for 1-2 days after the first 2-3 doses of the study medicine. Your health will be monitored by the study team during this time. All participants will receive elranatamab and at least 1 other anti-cancer medicine for multiple myeloma. Depending on which sub-study you qualify for, the treatments may vary, and you will be provided detailed information about the study medicines you will be taking.

You will visit the study doctor and receive the elranatamab study medicine each week. The other anti-cancer medicines will be given at different times depending on the dosing schedule. Your health will be monitored during each study visit. You will receive the study medicines until your multiple myeloma progresses, you experience side effects that are hard to manage, or you choose to stop receiving the study medicine. You and your doctor will determine other treatment options.

About one month after your last dose of study medicine, you will attend a final visit so the study team can observe your health. After that, the study team will contact you by phone to check on you.

Length of study 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

About the Study Medicine

We are studying if elranatamab (the study medicine), when given in combination with other anti-cancer medicines is safe and effective for people who have had prior treatment for their multiple myeloma.

Elranatamab is given as a shot under the skin (subcutaneous injection) — not through an IV infusion and is administered by a trained medical professional.

About the MagnestisMM-4 sub-studies

About the MagnestisMM-4 sub-studies

There are currently two sub-studies in the MagnestisMM-4 clinical trial. Both sub-studies are researching the study medicine (elranatamab) but are combined with different anti-cancer medicines. The study doctor will discuss with you in which of the sub-studies you may be eligible to participate.

Sub-Study A:  Elranatamab + Nirogacestat -- for people who are relapsed or refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-CD38 antibody -- Currently Enrolling

Sub-Study B:  Elranatamab + Lenalidomide and Dexamethasone -- for people who are relapsed or refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-CD38 antibody -- Currently Enrolling

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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What are the benefits and risks of taking part in the MagnetisMM-4 study?

People who take part in clinical trials are key to advancing medical research. By taking part in the MagnetisMM-4 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.

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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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Will I have to pay to be in the study?

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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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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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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