NCT05020236

Despite advances in multiple myeloma, more treatment options are needed

Have you previously received treatment for your multiple myeloma? A clinical study may be an option for you.

A phase 3 study known as MagnetisMM-5 is looking for around 555 participants with relapsed/refractory multiple myeloma. The study will allow us to learn more about how a study medicine, called elranatamab, works alone and in combination with a medicine called daratumumab compared to a current standard treatment (a combination of daratumumab + pomalidomide + dexamethasone).

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Who may participate

Participating in a clinical study is an important and personal decision. Thank you for considering the MagnetisMM-5 study.

This study is looking for around 555 participants with relapsed/refractory multiple myeloma.

Among other things, participants in this study must have previously tried at least one treatment regimen, but not more than four, including lenalidomide and a proteasome inhibitor (PI).

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 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

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.
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What to expect

If you are eligible and decide to enroll in the study, you will be randomly (by chance) assigned to one of three treatment groups.

Group 1 will receive elranatamab as an injection under the skin.

Group 2 will receive elranatamab and daratumumab as injections under the skin.

Group 3 will receive the standard of care, which is daratumumab as an injection under the skin and two oral medicines, pomalidomide and dexamethasone.

After your first week of treatment, you will have weekly visits for the first six months. After that, you will have visits every week or every other week.

The study team will perform tests and assessments throughout the study to monitor your health and safety as well as the effectiveness of the study medicine.

About a month after your last dose of the study medicine, there will be a final visit so the study team can observe your health and safety. After this visit, you will have phone calls at least once every three months so the study team can check in on your health. Some follow-up visits may be required.

Length of study treatment

The total length of this study will vary depending on how long you receive the study medicine, but it could last up to four years.

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

Number of study visits

Weekly visits for six months, then visits every week or every other week for up to four years.

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

Long-term follow up

One call or visit at least every three 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.

Potential benefits and risks of taking part in the MagnetisMM-5 study

Potential benefits and risks of taking part in the MagnetisMM-5 study

People who take part in clinical studies are key to advancing medical research. By taking part in the MagnetisMM-5 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.

About the study medicine

About the study medicine

We are evaluating the study medicine, elranatamab, to see if it is safe and effective for the potential treatment of multiple myeloma in people who have tried at least one treatment regimen for their multiple myeloma, but not more than four. In this study, participants will be assigned to one of three groups.

  • Group 1 will receive elranatamab as an injection under the skin.
  • Group 2 will receive elranatamab and daratumumab as injections under the skin.
  • Group 3 will receive the standard of care, which is daratumumab as an injection under the skin and two oral medicines, pomalidomide and dexamethasone

There is no placebo in this study.

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?

The study medicine, 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.

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How do treatment options for multiple myeloma work?

  • Immunomodulatory drugs (IMiDs) help adjust the immune response to kill cancer cells or make it difficult for them to grow
  • Anti-CD38 antibodies such as daratumumab kill cancer cells and may alter the immune response
  • Proteasome inhibitors (PIs) kill cancer cells by causing excess protein to build up inside of them
  • B-cell maturation antigen (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 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.

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Is there travel support available for participants in this study?

Travel to the study center and other expenses (such as meals) 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?

All records and documents pertaining to the study will be kept for at least 15 years. Some samples may be stored indefinitely.

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