Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
Status:
Completed
Trial end date:
2019-08-15
Target enrollment:
Participant gender:
Summary
Background:
- T cells are white blood cells that fight several cancers. One cancer therapy involves
removing a persons' T cells, changing them in a lab, and then returning them to the person.
Researchers want to see if this helps people with multiple myeloma.
Objective:
- To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple
myeloma.
Eligibility:
- Adults ages 18-70 with multiple myeloma that has not responded to standard therapies.
Design:
- Participants may be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Heart tests
- Bone marrow sample
- Multiple scans and X-rays
- Participants will have apheresis. Blood is removed through a needle in an arm. T cells
are removed. The rest of the blood is returned through a needle in the other arm.
- The cells will be changed in a laboratory.
- Participants will get 2 chemotherapy drugs over 3 days.
- Two days later, participants will check into the hospital. They will get an intravenous
(IV) catheter in an arm or chest vein. They will get the T cells through the IV in 1
infusion.
- After this, participants will stay in the hospital for at least 9 days and stay nearby
for 2 weeks. Then they will have blood tests and see a doctor.
- Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then
every 6 months. A bone marrow sample will be taken at the 2-month visit.
- Participants blood will be collected for several years. Participants will have an annual
physical at National Institutes of Health (NIH) for 5 years after the infusion. Then for
10 years they will answer health questionnaires.