The MagnetisMM-4 study will help us learn if a study medicine (elranatamab) can be both safe and effective when given in combination with another anti-cancer medicine being studied (nirogacestat) in people with relapsed/refractory multiple myeloma.

Thank you for considering MagnetisMM-4. If you participate in this study, you will receive attentive care from a skilled team of providers, researchers, and coordinators and can help advance a potential medicine for people with multiple myeloma.

Who may participate

 

MagnestiMM-4 may be an option for women and men who:

  • Are 18 years of age and older
  • Have multiple myeloma that has come back after prior treatment with an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody

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-4, you will play an important role in helping to represent your community and in helping us understand how treatments work across different races, 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

If you choose to participate, you will sign the informed consent document and take part in the screening period to confirm you meet all eligibility criteria. The screening period will take up to 28 days, with 2-3 visits to the study clinic.

All participants who qualify for the study will receive elranatamab and nirogacestat. There is no placebo in MagnestisMM-4. (A placebo does not have any medicine in it but looks just like the medicine being studied.)

When you begin treatment with elranatamab, you will stay in the hospital for 1-2 days after the first 2-3 doses. Your health will be monitored by the study team during this time.

You will receive the study medicines until the study doctor thinks you are no longer benefiting from these treatments or you choose to stop receiving them.

Length of study treatment

Up to 2+ years

Number of study visits

About 1 per week while receiving treatment

Long-term follow up

1 call or visit every 3 months

About the Study Medicines

Portrait of Woman 2 for Multiple Myeloma – Pfizer Clinical Trials
Portrait of Woman 2 for Multiple Myeloma – Pfizer Clinical Trials

About the Study Medicines

Elranatamab is given as a shot under the skin (subcutaneous injection) and is administered by a trained medical professional. Elranatamab 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.

Nirogacestat is also being studied for the treatment of multiple myeloma. It is taken by mouth and can be taken with or without food. Nirogacestat is being given in MagnestisMM-4 because it is believed that nirogacestat may help elranatamab work better.

Potential 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.

Potential benefits and risks of taking part in the MagnetisMM-4 Study

Portrait of Man and Boy for Multiple Myeloma – Pfizer Clinical Trials
Portrait of Man and Boy for Multiple Myeloma – Pfizer Clinical Trials

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 do relapsed 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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Could I receive placebo in MagnestisMM-4?

All participants who qualify for the study will receive elranatamab and nirogacestat. There is no placebo in MagnestisMM-4. (A placebo does not have any medicine in it but looks just like the medicine being studied.)

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How does elranatamab work?

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.

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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 is Informed Consent?

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.

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Is taking part in this clinical trial voluntary?

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.

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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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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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