Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
Completed · Phase 1
Conditions studied: Myeloma, Plasma-Cell, Myeloma-Multiple
In brief
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.
Key facts
- Study ID
- NCT02215967
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2014-08-12
- Expected to finish
- 2019-08-15
- Last updated by the study team
- 2019-10-08
Who can join
Age: 18 and older, up to 73. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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