If you have been newly diagnosed with multiple myeloma and are not eligible for stem cell transplantation or are not considering transplantation at this time, this study may be a good fit

The MagnetisMM-6 study is researching a study medicine (elranatamab) in combination with two standard multiple myeloma treatments (daratumumab and lenalidomide). 

The goal of this study is to learn about the effects of the elranatamab combination compared to a combination of only standard treatments, to establish whether the elranatamab combination may better treat multiple myeloma.

Who may participate

Participating in a clinical study is an important and personal decision. We are currently looking for people to join Part 2 of the MagnetisMM-6 study. 

Part 2 of the MagnetisMM-6 study may be an option for people who are 18 years or older and:

  • Have been newly diagnosed with multiple myeloma
  • Are not eligible for a stem cell transplant, or are not considering a stem cell transplant at this time 

There are other requirements for participation in Part 2 of the MagnetisMM-6 study. The study doctor can explain these to you.

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.

View more eligibility criteria

Additional eligibility criteria

Part 2 of the MagnetisMM-6 study may be an option for people who are 18 years or older and: 

  • Have been newly diagnosed with multiple myeloma
  • Are not eligible for a stem cell transplant, or are not considering a stem cell transplant at this time

You may not qualify for the study if you:

  • Have certain medical conditions, including cardiovascular diseases, neuropathies, and other active infections
  • Have had other cancers in the past 3 years (except for some skin cancers)
  • Have already had treatment for multiple myeloma (except for a short course of corticosteroids, such as dexamethasone)

What to expect

If Part 2 of this study is a good fit for you and you choose to take part, you will be randomly assigned with a 50% (1 in 2) chance to ‘Arm A’ or ‘Arm B’:

  • Arm A - You will receive elranatamab + daratumumab + lenalidomide (referred to as EDR)
  • Arm B - You will receive daratumumab + lenalidomide + dexamethasone (referred to as DRd)

This is an open-label study, which means that you and your study doctor will know which treatment arm you will be assigned to. 

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 the last dose of your study treatment, there will be a visit to allow the study team to observe your health and safety. You will then continue to have phone calls or visits about every one to three months so the study team can check on your health.

Length of study treatment

Depends how long you receive the study medicine

Number of study visits

Up to four visits over each 28-day cycle

Long-term follow up

One call or visit about every one to three months

About the study medicine

The study medicine, elranatamab, is thought to work as a bispecific antibody. 

Bispecific antibodies differ to monoclonal antibodies as they can attach to two different types of cells rather than one. 

Bispecific antibodies are currently being researched by scientists as potentially effective treatments for different diseases, especially cancers. 

Bispecific antibodies with one part that binds to a cancer cell and one part that binds to an immune system cell may cause the immune system to attack and destroy the cancer cell. 

Elranatamab, the study medicine in this trial, is thought to work by connecting T-cells (certain immune system cells) to myeloma cells (cancer cells). 

Connecting these cells may activate the immune cells, potentially destroying the myeloma cells.

About the study medicine

Woman with Multiple Myeloma -– Pfizer Clinical Trials
Woman with Multiple Myeloma -– Pfizer Clinical Trials

Potential benefits and risks of taking part in the MagnetisMM-6 study

Although there is no guarantee that participants will benefit from receiving either study treatment combination, participants will have their health closely monitored for the duration of this study, and will help advance medical research that may benefit the multiple myeloma community 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 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-6 study

older woman with multiple myeloma – Pfizer Clinical Trials
older woman with 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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How does this study drug work?

The study drug 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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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 trial, 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 trials also help us learn more about any 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 medicine, approved medicines, and all study-related care and procedures are provided at no cost. You don’t need health insurance to join this clinical trial. 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 clinical trial?

Travel to the study site 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 trial 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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