Have you tried several treatments for your multiple myeloma? A clinical trial may be an option for you.
Each day we learn more about relapsed/refractory multiple myeloma, and researchers continue to work on ways to treat it. This study is researching a potential treatment for multiple myeloma in people for whom at least three types of treatment have not been effective.
Who may participate? This study is looking for about 150 participants with relapsed/refractory multiple myeloma. Among other things, participants must have tried, but not had success with, each of the following treatments:
At least 1 IMiD (immunomodulatory drug), such as lenalidomide or pomalidomide
At least 1 PI (proteasome inhibitor), such as bortezomib and carfilzomib
At least 1 anti-CD38 mAB (monoclonal antibody), such as daratumumab or isatuximab
If you are not sure which treatments you have received, please ask your doctor.
What to expect? If you’re interested in participating, you will review and sign the informed consent document and continue with the screening process. The screening period will take up to 28 days, with 1-2 visits to the study location.
If you’ve met all eligibility criteria, the study treatment period begins. You will stay in the hospital for at least two days, so that your health can be monitored by the study team. The study drug will be given by a medical professional as an injection under the skin. Everyone who takes part in the study will receive the study drug (there is no placebo).
For the next 6 months, you will see the study doctor and receive the study drug at weekly visits. The study team will perform physical exams and other tests to monitor your health. After the initial 6 months, the dosing schedule may be adjusted. If the study doctor sees that your multiple myeloma has progressed or if you experience any side effects that are difficult to manage, the study drug will be discontinued.
Approximately one month after the last dose of study drug, there will be a final visit so the study team can observe your health. After that, the study team will contact you by phone about once every three months for up to five years to check on your health.
About the study drug: We are assessing if the study drug is safe and effective for people who have tried at least three other unsuccessful types of treatments for their multiple myeloma. The study drug is given as a subcutaneous injection—that is, a shot under the skin, rather than an IV infusion. The study drug will be administered by a trained medical professional. We believe the study drug could work by binding to T-cells (a type of cell in the immune system) and to myeloma cells (cancer cells), potentially causing the immune cells to kill the cancer cells.