MagnetisMM-6: enrolling people with multiple myeloma

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A clinical trial to assess a potential treatment option for multiple myeloma

Despite advances in cancer care, there is no cure for multiple myeloma. Approved treatments may not work for everyone, and some treatments lose effectiveness over time.
The MagnetisMM-6 (MM6) clinical trial is exploring whether the study medicine (elranatamab) is safe and effective in treating people with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant. MM6 is looking at the benefits of the study medicine with other approved medicines (daratumumab + lenalidomide) for the treatment of multiple myeloma versus an approved combination therapy (daratumumab + lenalidomide + dexamethasone). There is no placebo (inactive medicine) group in this trial. All participants will receive active medicines.
The MM6 trial is Phase 3, which is the last phase of testing to be completed before the study medicine is submitted for regulatory review and potential approval and is enrolling around 1116 people.
The trial is divided into two distinct parts: Part 1 and Part 2. For Part 1, up to 246 people with relapsed/refractory multiple myeloma and newly-diagnosed multiple myeloma who are transplant ineligible are expected to participate. For Part 2, approximately 870 people with newly diagnosed multiple myeloma who are transplant-ineligible are expected to participate. Part 2 enrolment is expected to begin in mid-2024.

Who may participate

Participating in a clinical trial is an important and personal decision.
Thank you for considering MM6.

You may qualify* for the trial if you:
  • Have newly diagnosed multiple myeloma or have relapse refractory multiple myeloma

  • Have not had prior treatment with certain therapies (the study team can explain what these are)

  • Are not eligible for a stem cell transplant

  • Are at least 18 years of age (or minimum age of consent)

  • Are female and are not pregnant or breastfeeding

  • Are a male or female of childbearing age and agree to the use of certain contraception

You may not qualify* for the trial if you:
  • Have certain medical conditions, including cardiovascular diseases, neuropathies, and other active infections

  • Have had other cancers in the past 3 years

*There are other requirements for taking part in this trial.

Condition

Multiple myeloma

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The disease, disorder, syndrome, illness, or injury that is being studied.

Age

18+ years 

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The age a person must be to participate in a clinical trial.

Sex

Male or female

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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 gender.

If you’re interested in participating, you will need to visit a study site. At the study site, you will review and sign an informed consent document and complete a screening process to see whether you meet all eligibility criteria (guidelines for who can participate). Only the research study staff can determine if you qualify to enrol in the trial.

What to expect

Length of study treatment

Approximately six years or longer
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Length of study treatment is the length of time the study participants will receive the study treatment. This will vary depending on how participants tolerate the treatment, how their cancer responds, and their personal choice. 

Number of study visits

1-4 visits per 28-day cycle, until end of study treatment

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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 3 months 

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Some trials 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 trial. This long-term follow up is to collect additional information on the study medicine over time.

MM6 is a randomized, open-label trial.
  • ‘Randomized’ means participants will be assigned to a treatment group by chance. Neither you nor the study doctor can choose which treatment group you will be part of.
  • ‘Open-label’ means that both you and the study doctor will know which treatments you are receiving.
During your participation, you will have regular study visits and undergo tests and assessments to monitor your health and safety, as well as the effectiveness of the study medicines.You will receive the treatments given in the trial until you choose to stop taking part in the trial, you have side effects that become too severe, the study doctor thinks you are no longer benefitting from the study medicines, or tests show that your cancer is getting worse.
About a month after your last dose of the study medicines, there will be a final required visit to the study site. After this visit, the study team will contact you by phone every three months to check in on your health. Some additional follow-up visits may be required, depending on how your cancer responds. You are free to stop being in this trial at any time and for any reason. If you choose to stop participating in the trial, it will not affect your regular medical care or any benefits to which you are entitled.
About the study medicine
The study medicine (elranatamab) is given as a subcutaneous (SC) injection under the skin, not through an IV. Elranatamab is thought to work by connecting certain immune system cells, known as T-cells, to myeloma cells. Connecting these cells activates the immune cells to kill the myeloma cells.
About the comparator arm
In MM6, the study medicine combination is being compared to an approved combination therapy, currently used for people with newly diagnosed multiple myeloma who are not eligible for a stem cell transplant. There is no placebo medicine given in MM6, so all participants will receive active treatment for their disease.

Potential benefits and risks of taking part in MM6

People who take part in clinical trials are key to advancing medical research. By joining this clinical trial, you may help improve treatment for people with multiple myeloma. You are helping to represent your community (race, ethnicity, age, and sex) and all people affected by this disease.
Over the course of the trial, your health may get better, get worse, or stay the same. You will be given more information about the potential risks before agreeing to participate.

Find a clinical site near you

The MM6 trial is taking place at research sites in multiple countries worldwide.

To find your nearest study site, please enter your zip code and select the optimal distance to view on the map from the drop-down menu:

      Frequently asked questions

      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 tumours and leaving a person vulnerable to infection.

      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. 

      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.

      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. If you choose to stop participating in the trial, it will not affect your regular medical care or any benefits to which you are entitled.
      Clinical trials are important to understand more about potential treatment options for all sorts of conditions. Clinical trials gather information about the treatment that is being researched, including whether the treatment is safe and effective. All medicines that become available today for use in people are first tested in trials involving hundreds to thousands of volunteers.
      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 trial. However, you (or your health insurance provider) may be responsible for medical expenses that are part of your usual healthcare. Talk with the team at your study site to find out exactly what is covered.
      Travel to the study centre and other expenses (such as meals) may be covered. Please discuss the details with the team at your study site.
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