EN

MagnetisMM-32: enrolling for people with relapsed/ refractory 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.

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

The MagnetisMM-32 (MM32) clinical trial is exploring whether a study medicine is safe and effective in treating people with multiple myeloma that has come back after prior treatment. MM32 is looking at the benefits of treatment with the study medicine alone versus treatment with several other medicines given together.

Who may participate?

Thank you for considering the MM32 study. Participating in a clinical study is an important and personal decision.
This study is looking for around 500 participants with relapsed/refractory multiple myeloma.

You may qualify* for the study if you:

  • Have received 1 to 4 rounds of treatment for multiple myeloma, including anti-CD38 antibody therapy and a lenalidomide-containing regimen**
  • Have multiple myeloma that has gotten worse or has not responded to your last round of treatment
  • Are at least 18 years of age (or minimum age of consent)

You may not qualify* for the study if you:

  • Have certain medical conditions, such as heart disease, nerve disorders, or ongoing infections
  • Have had other cancers in the past 3 years
  • Have had certain types of prior treatments for multiple myeloma
  • Are pregnant, breastfeeding, or able to get your partner pregnant

* There are other requirements for taking part in this trial.
** If you are not sure which treatments you have received, please ask your doctor.

If you’re interested in participating, you will first be given an informed consent document to review and sign. You will then visit the study doctor’s office during a screening process to see whether you meet the eligibility criteria and are able to take part.
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 enrol in the study.

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

Relapsed/refractory multiple myeloma

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

18+ years (or minimum age of consent)

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.

Male or Female
People of all backgrounds can be diagnosed with multiple myeloma, and the condition is more likely to develop in races and ethnicities often underrepresented in clinical trials. By choosing to take part in MM32, you will play an important role in helping to represent your community and in helping us understand how the treatments in this study work across different race, ethnicities, ages, and sexes. Your participation may potentially improve the treatment options and quality of life for people with multiple myeloma in the future.

What to expect

MM32 is a Phase 3, randomized, open-label study.

  • ‘Phase 3’ clinical trials look at the safety and effectiveness of the study medicine. Phase 3 is the last phase of testing to be completed before the study drug is submitted for regulatory review and potential approval.
  • ‘Randomized’ means participants will be assigned to a treatment by chance (like flipping a coin). Neither you nor the study doctor can choose which treatment you will receive.
  • ‘Open-label’ means that both you and the study doctor will know which treatment you are receiving.

If you are eligible and decide to take part in the study, you will be randomly assigned to receive:

  • The study medicine as an injection under the skin. 

OR one of three combination treatments. Your study doctor will decide which of the three combination treatments is best for you.

You will have a 50% (1 in 2) chance of receiving the study medicine or one of the combination treatments.
There is no placeboA placebo looks like the study medicine, but has no active ingredients. medicine given in MM32, so all participants will receive active treatment for their disease.
The frequency of study visits depends on which treatment(s) you receive. You will visit the study doctor 1 to 6 times every month until you stop receiving study treatment(s).
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 treatment(s).
As a participant in the study, you will receive your assigned treatment(s) until your multiple myeloma has gotten worse, you experience side effects that are hard to manage, or you choose to stop receiving the study treatment(s). The total time you will spend in this study will vary depending on how long you receive study treatment(s).
About a month after your last dose of the study treatment(s), there will be a final visit so the study team can observe your health and safety. After these visits, you will have phone calls at least every one to three months so the study team can check in on your health. Some follow-up visits may also be required.

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

The total length of this study will vary depending on how long you receive the study treatment(s), but it could last up to five years.

The frequency of study visits depends on which treatment you receive. You will visit the study doctor 1 to 6 times every month until you stop receiving the study treatment.

Varies depending on study group.

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.

One call or visit at least every one to three months.

Potential benefits and risks of taking part in the MM32 study

People who take part in clinical studies are key to advancing medical research. By taking part in the MM32 study, you will be aiding medical research which may help others with multiple myeloma in the future.
By participating in this study, you will receive treatment and close monitoring of your multiple myeloma. You will also help answer whether treatment with the study medicine is safe and more effective at keeping multiple myeloma from getting worse than combination treatments commonly provided to patients whose multiple myeloma has worsened or come back after prior treatment.
Over the course of the study, your 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 known 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

We are evaluating the study medicine, to see if it is safe and effective for the treatment of multiple myeloma in people who have previously received 1-4 rounds of treatment for multiple myeloma.
The study medicine is given as a subcutaneous (SC) injection under the skin. It 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.

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 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.
  • Immunomodulatory drugs (IMiDs) help adjust the immune response to kill cancer cells or make it difficult for them to grow.
  • Anti-CD38 antibodies kill cancer cells and may alter the immune response.
  • Proteasome inhibitors (PIs) kill cancer cells by blocking the destruction of pathways in the cells that remove excess proteins. In doing this, the cells die.
  • B-cell maturation antigen (BCMA) antibodies target a protein found on the surface of myeloma cells.

Relapse is when a treatment works for a while and then stops, which leads to the disease coming back. 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.

The study treatment(s) 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.

Travel to the study centre and other expenses (such as meals) may be covered. Please discuss the details with your study team.

Find answers to other FAQs

FAQs

Find a clinical site near you

The MM32 study is taking place at research sites in multiple countries worldwide.

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

      How clinical

      trials work

      Steps to join 

      a clinical trial

      Protecting 

      your safety 

      & privacy

      FAQs

      en_USEN-AU
      cs_CZCS fr_FRFR-FR en_US_usEN-US en_GBEN-GB es_CLES-CL en_USEN-AU