Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02215967|
Recruitment Status : Completed
First Posted : August 13, 2014
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
- 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.
- To test the safety of giving anti-B-Cell Maturation Antigen T cells to people with multiple myeloma.
- Adults ages 18-70 with multiple myeloma that has not responded to standard therapies.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Myeloma, Plasma-Cell Myeloma-Multiple||Drug: Cyclophosphamide Drug: Fludarabine Biological: Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma|
|Actual Study Start Date :||August 12, 2014|
|Actual Primary Completion Date :||April 25, 2019|
|Actual Study Completion Date :||August 15, 2019|
Experimental: Multiple Myeloma
Dose Escalation with 5 dose levels based on the patients actual bodyweight
300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3
Other Name: Cytoxan
30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3
Other Name: Fludara
Biological: Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells
0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
- Number of Participants With Dose Limiting Toxicities [ Time Frame: After the start of treatment and up to 60 days ]Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) [ Time Frame: Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells. ]Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- Number of Participants With Best Response [ Time Frame: From start of treatment up to 84 weeks ]Best response was assessed by the International Myeloma Working Group response criteria. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein. Progressive Disease (PD) is increases of greater or equal to 25% from the lowest post-treatment (nadir) value in serum M-component or urine component or percentage of bone marrow plasma cells. Definite development of new bone lesions or new plasmacytoma. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis. Stringent Complete Remission (sCR) is normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry. Complete Remission is negative immunofixation on the serum and urine. Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or PD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215967
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||James N Kochenderfer, M.D.||National Cancer Institute (NCI)|