NCT05675449

A clinical trial to learn about the effects of combined treatments for multiple myeloma that has returned or not responded to previous treatment

The MagnetisMM-20 study is looking for around 12 people with multiple myeloma that has returned or not responded to previous treatment.

The study is exploring the effects of an investigational combination of treatments given in addition to regular medical care, and whether it can help people with multiple myeloma.

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Who may participate

Participating in a clinical study is an important and personal decision. Thank you for considering the MagnetisMM-20 study.

This study may be an option for men and women who:

  • Are at least 18 years old
  • Have received at least 1 but no more than 3 types of treatment for multiple myeloma
  • Have relapsed or had a recurrence of multiple myeloma following treatment

There are other requirements for taking part in this study. We will explain these to you if you’d like to learn more.

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

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 for the study, there will be a minimum of 1 hospitalization period for the first two doses of the study treatment (minimum of 2 days for the first dose and 1 day for the second dose). Afterwards, you will visit the site once a week for study treatment.

You will continue to receive the study medicine until your cancer gets worse, the study doctor thinks you are no longer benefitting from the study medicine, you have side effects that become too severe, or you choose to stop taking part.

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 treatments.

The total length of this study will vary depending on how long you receive the study medicine, it could last two years or longer.

Length of study treatment

This study could last two years or longer.

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

Number of study visits

Cycle 1 has up to 3 clinic visits. Then there are 1-4 visits per 28-day cycle.

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 at least every month

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 treatments

About the study treatments

We are exploring whether a combination of treatments is safe and effective for people with multiple myeloma. The study treatments are given as a subcutaneous injection, an intravenous infusion, or as a tablet taken by mouth. Study treatments given as a subcutaneous injection or as an infusion are administered by a trained medical professional.

Potential benefits and risks of taking part in this study

Potential benefits and risks of taking part in this study

People who take part in clinical studies are key to advancing medical research. By taking part in the MagnetisMM-20 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 treatments.

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?

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.

Carfilzomib is known to block actions of certain proteins which can kill the myeloma cells.

Dexamethasone is used in the treatment of multiple myeloma as an anti-inflammatory to reduce the number of white-blood cells moving to the myeloma cells, it can also potentially kill the 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 study .

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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Why do we need clinical trials?

Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical research studies also help us learn more about the side effects of a potential treatment and to understand whether the possible benefits outweigh the risks.

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

The study treatments 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 and refer to the informed consent document for details on reimbursement and compensation.

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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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