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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 the study medicine (elranatamab) 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, including cardiovascular diseases, neuropathies, and other active 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.
Každá klinická studie má vlastní směrnice ohledně toho, kdo se jí může účastnit. Jsou to takzvaná kritéria způsobilosti. Ovšem o tom, zda jste vhodným adeptem pro zařazení do studie, mohou rozhodnout pouze pracovníci výzkumné studie.

Onemocnění, porucha, syndrom, nemoc nebo zranění, které studie zkoumá. 

Relapsed/refractory multiple myeloma

Věk, jehož musí osoba dosáhnout, aby se mohla účastnit klinického hodnocení.

18+ years (or minimum age of consent)

Pohlaví osob, které se mohou účastnit klinického hodnocení. Pohlaví je kategorie, která byla jedinci přiřazena při narození. Způsobilost na základě pohlaví je něco jiného než způsobilost na základě genderové identity.

Muž nebo žena
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.

Co očekávat

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

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

  • The study medicine, elranatamab, as an injection under the skin.

OR one of the following combination treatments.Your study doctor will decide which one of the three combination treatments is best for you (EPd, PVd, or Kd):

  • EPd: this combination includes three medications (elotuzumab, pomalidomide, and dexamethasone) that are given in 28-day cycles: elotuzumab is given by needle into your vein at the study clinic, and dexamethasone and pomalidomide are taken by mouth at home.
  • PVd: this combination includes three medications (pomalidomide, bortezomib, and dexamethasone) that are given in 21-day cycles: bortezomib is given by a shot under the skin or needle into your vein at the study clinic, and dexamethasone and pomalidomide are taken by mouth at home.
  • Kd: this combination includes two medications (carfilzomib and dexamethasone) that are given in 28-day cycles: carfilzomib is given by needle into your vein at the study clinic and dexamethasone is taken by mouth at home.

You will have a 50% (1 in 2) chance of receiving the study medicine, elranatamab, or one of the combination treatments above (EPd, PVd, or Kd).

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.

Délka hodnocené léčby je doba, po kterou účastníci studie dostávají hodnocenou léčbu.

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.

Některé studie vyžadují, aby tým studie zůstal po určitou dobu s účastníkem v kontaktu i poté, co dotyčný dokončí hlavní část studie. Toto dlouhodobé následné sledování slouží ke shromažďování dodatečných informací o hodnoceném přípravku v čase.

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, elranatamab, 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.

O hodnoceném přípravku

We are evaluating the study medicine elranatamab, 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, elranatamab, 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.

Časté dotazy

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.

  • 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.

Cestování do centra provádějícího studii i další výdaje (např. za jídlo) mohou být hrazeny. Podrobnosti proberte s týmem studie.

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Časté dotazy

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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:

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