NCT05014412

Despite recent progress in treatment of multiple myeloma, additional treatment options are still needed.

We’re hoping to learn more about a study medicine called elranatamab to better understand if it could potentially help treat relapsed/refractory multiple myeloma.

Card Summary Component

Who may participate

Participating in a clinical trial is an important and personal decision. Thank you for considering the MagnetisMM-9 trial.

This trial is looking for about 119 participants with relapsed/refractory multiple myeloma. Among other things, participants in this trial must have tried but not had success with their most recent multiple myeloma therapy and at least one of each of the following treatments:

  • Proteasome inhibitor (PI)
  • Immunomodulatory drug (IMiD)
  • Anti-CD38 monoclonal antibody (mAb)

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

If you’re 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 will take up to 28 days, including at least 1 visit to the study 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.

What to expect

The treatment period begins after screening, where you will stay in the hospital two to three times 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 or every other week to receive injections and complete various health assessments, which then may be adjusted.

You will receive the study medicines(s) until your condition progresses, you experience unmanageable side effects, or you choose to stop receiving the study medicine(s).

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

The total length of treatment will vary depending on how you tolerate and how your disease responds to the study medicine. Even if you stop taking the study medicine, you will be asked to stay in the study for at least two years.

Length of study treatment

Up to 2+ years

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

Number of study visits

Up to 53 in the first year

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

Long-term follow up

1 phone call every 3 months

Some studies require the study team to stay in contact with the participant for a period of time after the main part of the study is completed. This long-term follow up is to collect additional information on your health and the study medicine over

About the study medicine

About the study medicine

We are researching the safety and effectiveness of the study medicine, elranatamab, given alone (Part 1 and Part 2) or in combination with dexamethasone for a duration of 6 cycles (Part 3) in people who have tried, but not had success with their most recent multiple myeloma therapy or treatments from three different drug classes.

Elranatamab is a type of treatment called a B-cell maturation antigen (BCMA) and it will be given to all participants as a shot given under the skin (called a subcutaneous injection), not through an IV. The study medicine dexamethasone is a treatment with anti-myeloma activity and has been an integral part of most combination regimens in multiple myeloma therapy.

We believe elranatamab could work by binding to T-cells (a type of cell in the immune system) to myeloma cells (cancer cells), potentially causing the immune cells to kill the cancer cells. No placebo is used in this trial.

About the study medicine

What are the benefits and risks of taking part in the MagnetisMM-9 trial?

What are the benefits and risks of taking part in the MagnetisMM-9 trial?

People who take part in clinical trials are key to advancing medical research. By participating in the MagnetisMM-9 trial you will be aiding medical research, which may help others with multiple myeloma in the future.

Over the course of the trial, your health may get better, worse, or stay the same. If you consider taking part in the trial will be given a complete list of risks and possible discomforts before agreeing to participate. As with any therapy, there may be a reaction to the study medicine.

What are the benefits and risks of taking part in the MagnetisMM-9 trial?