BMT CTN 1902 - BCMA for MM s/p Auto and lenalidomide (Multiple Myeloma)
What is the Purpose of this Study?
We are doing this study to see if CAR T-cell therapy and maintenance therapy with the drug lenalidomide can help delay multiple myeloma from coming back.
Multiple Myeloma
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with multiple myeloma
- Have received an autologous stem cell transplant
For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.
What is Involved?
If you choose to join this study, there will be a screening period to find out if you are eligible. During this period, you will:
- Have a physical exam
- Have a bone survey (series of x-rays of all the bones in the body)
- Have blood draws and give urine samples
- Have bone marrow samples taken
If you are eligible, we will collect blood and marrow samples during the study to do the following:
- Check if the treatment is working. This is a standard way to keep track of multiple myeloma.
- Check your immune response after CAR T-cell therapy. This is not standard care.
- Store them for future research. This is not standard care.
About 14 days after screening, T-cells will be collected from your blood during a procedure called leukapheresis. During this procedure, you will be connected to a machine for 2 to 4 hours. You will have an intravenous (IV) line placed into a vein in each arm. Sometimes the veins in the arm do not allow enough access to the blood, in which case a central intravenous access (catheter/central line) may need to be placed, usually at one side of your neck. Blood is taken out of one of the IVs and is sent through a machine that collects the immune cells, and the rest of the blood is then given back to you through the second IV access. You will be monitored carefully during the procedure. This is not standard care, and the study will pay for it.
If you have an unsuccessful initial apheresis, you may proceed to a second apheresis in order to make your CAR T-cell therapy. The CAR T-cell therapy in this study, called BB2121, is engineered from your own T-cells that we collect from the leukapheresis procedure.
About 1 month after your T-cells are turned into BB2121, you will start chemotherapy to prepare your body to receive the CAR T-cells. You will receive 2 chemotherapy drugs: fludarabine and cyclophosphamide. They are given to you through an intravenous (IV) infusion on 3 different days. This is not standard care, and the study will pay for the chemotherapy drugs.
Doctors will check your health before you get the chemotherapy. If you are not healthy enough to receive it, you may not be able to receive the CAR T-cell therapy. Your doctor will talk to you about other treatment options if this happens.
Within 3-17 days after chemotherapy, you will receive the CAR T-cells through an IV infusion. This is not standard care, and the study will pay for the CAR T-cells. Doctors will check your health before you get the CAR T-cells. If you are not healthy enough to receive them, your doctor may wait and check again later. If you still are not healthy enough after 2 weeks, you may have to get the chemotherapy again, or you may not be able to get the CAR T-cell therapy. Your doctor will talk to you about other treatment options if this happens.
You will see the doctor on days 4, 7, 10, 14, 21, 30, 60, 90, 180, 270, 365 after receiving your CAR T-cells for exams to see how you are doing.
About 1-6 months after the CAR T-cell infusion, you will start taking the pill lenalidomide. You will take it each day for 21 days, then you will have 7 days off. You will repeat this schedule (called a cycle) for about 12 months. Your doctor will talk with you about ordering, receiving, and taking lenalidomide. Your doctor will watch your health closely while you are taking lenalidomide. Your doctor may change your dose based on how your body handles the treatment. If your multiple myeloma comes back, you will stop taking it.
The study will last about 15 months.