Multiple Myeloma Clinical Trial
Official title:
Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.
Design:
Participants may be screened with:
Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple
scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a
healthy donor. Blood is removed through a needle in an arm. 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 5
days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will
get the split doses CART cells on day0, day1, day2 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 at 1, 2, 3, 6, 9 and 12 months after the infusion, then
every 6 months until two years after infusion. A bone marrow sample will be taken at the
3-month visit.
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