Plan Development for Giving Teclistamab in the Outpatient Setting

This study is specifically for adults aged 18 and over who have multiple myeloma that has come back, or hasn't responded to at least three different types of previous treatments. These treatments must have included certain medicines like a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Also, your doctors need to confirm that your cancer has started to grow again despite your last treatment. You should generally be in good health for someone with your condition, and specific blood test results will be checked to make sure it's safe for you to take part. You'll also need to have at least one person who helps look after you (a caregiver) who can also take part in the study.

If you are a woman who could become pregnant, you would need to use highly effective contraception during the study. Similarly, men would need to use condoms during the study and follow specific guidelines afterwards to prevent pregnancy.

If you join this study, you will receive the medicine teclistamab. The main focus is on how this medicine can be given outside of a hospital, so you'll likely have your treatments at a specific cancer centre. This part of the study is mainly about setting up the best processes for giving teclistamab in an outpatient setting, rather than testing the medicine's effectiveness itself.

Throughout the study, doctors and nurses will closely monitor your health with regular check-ups, blood tests, and other assessments. They'll be looking for how you react to the treatment and making sure you are safe. Your caregiver will also be asked to answer questions about their experiences and what's involved in helping you during this time. The total duration of your participation will depend on how you respond to the treatment and the study's specific plan, but you will continue to receive teclistamab even after the initial study period if it is helping you, following standard guidelines.