NCT05462639

Introducing a clinical trial for people with relapsed/refractory multiple myeloma who have exhausted all other treatment options

The MagnetisMM studies are researching if the study medicine, elranatamab, can be both safe and effective in people with multiple myeloma. This “expanded access” trial is intended to provide access to elranatamab for people with relapsed/refractory multiple myeloma (RRMM) whose cancer has not responded to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody, until it becomes commercially available.

If you have RRMM and don’t have access to other treatment options, this trial may be an option for you

Card Summary Component

Who may participate

Participating in a clinical trial is an important and personal decision. Thank you for considering the MagnetisMM-17 trial.

This trial is looking for people with RRMM whose cancer has not responded to at least one of the following treatments:

  • Proteasome inhibitor (PI), such as bortezomib or carfilzomib
  • Immunomodulatory drug (IMiD), such as lenalidomide or pomalidomide
  • Anti-CD38 monoclonal antibody (mAB), such as daratumumab or isatuximab

If you are not sure which treatments you have received, please ask your doctor.

If you are interested in participating, you will review and sign the informed consent document and continue with the screening process to confirm whether you’ve met all eligibility criteria. The screening period can take up to 28 days, including at least 1 visit to the trial location.

Condition

Relapsed/refractory 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.

Card Summary Component

What to expect

The treatment period for this trial begins after the screening visit. At the beginning of the treatment period you will stay in the hospital for 2 days after the first dose and 1 day after the second dose, so that your health can be monitored by the trial team.

For the first six months, you will be asked to see the trial doctor every week to receive injections of the study medicine and complete various health assessments. After six months, your study treatment schedule may be adjusted.

Approximately one month after the last dose of study medicine, there will be one follow-up visit so the trial team can observe your health and safety. Then, the trial team will contact you by phone about once every three months (or you may have a visit) to check on your health.

Length of study treatment

This will depend on your disease, any side effects, or commercial availability

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

Number of study visits

This will depend on your disease, any side effects, or commercial availability

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Long-term follow up

You will be contacted every 3 months to check your health status

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 medicine

This trial is intended to provide access to the study medicine, elranatamab, for people who have exhausted all other treatment options for multiple myeloma. The study medicine is a type of treatment called a bi-specific antibody and it will be given to all participants as a shot under the skin (called a subcutaneous injection).

The study medicine is thought to work by connecting T-cells (a type of cell in the immune system) to myeloma cells (cancer cells), potentially activating the immune cells to kill the cancer cells.

About the study medicine

Potential benefits and risks of taking part in the MagnetisMM-17 trial

By taking part in the MagnetisMM-17 trial, participants who do not have access to other comparable/alternative therapy will be able to access elranatamab, before it becomes commercially available.

Over the course of the trial, a participant’s health may get better, get worse, or stay the same. People who are considering taking part in the trial 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 medicine.

Potential benefits and risks of taking part in the MagnetisMM-17 trial