Phase 1
Completed N=30
Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma
Multiple Myeloma · Myeloma-Multiple
Source: ClinicalTrials.gov NCT02215967 ↗
Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities — 0; 0; 0; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities |
0; 0; 0; 4; 0; 0 | — |
| PRIMARY Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) |
3; 3; 4; 16 | — |
| SECONDARY Number of Participants With Best Response |
1; 0; 0; 4; 2; 3 | — |
Eligibility Criteria
- INCLUSION CRITERIA:
2.1.1.1 Multiple Myeloma criteria
- Clear B-cell maturation antigen (BCMA) expression must be detected on greater than 50% of malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. These assays must be performed at the National Institutes of Health. It is not required that the specimen used for BCMA determination comes from a sample that was obtained after the patient's most recent treatment. BCMA expression will need to be documented on the majority of malignant plasma cells at some time after the original anti-BCMA chimeric antigen receptor (CAR) T-cell infusion in all patients undergoing a second anti-BCMA CAR T-cell infusion. If paraffin embedded unstained samples of bone marrow involved with multiple myeloma (MM) or a plasmacytoma are available, these can be shipped to the National Institutes of Health (NIH) for BCMA staining, otherwise new biopsies will need to be performed for determination of BCMA expression.
- Bone marrow plasma cells must make up 30% or less of total bone marrow cells based on a bone marrow biopsy performed within 30 days of the start of protocol treatment.
- Patients must have received at least 3 different prior treatment regimens for multiple myeloma
- Patients must have measurable MM as defined by at least one of the criteria below.
a. One or more of these abnormalities defines measurable disease:
- Serum M-protein greater or equal to 1 g/dl (10 g/l).
- Urine M-protein greater or equal to 200 mg/24 h.
- Serum free light chain (FLC) assay: involved FLC level greater or equal to10 mg/dl (100 mg/l) provided serum FLC ratio is abnormal.
- A biopsy-proven plasmacytoma
- Patients must have multiple myeloma that meets the criteria for one of the following Disease categories: (1) progressive disease or (2) relapse from Complete Remission (CR) as described in the International Uniform Response Criteria for Multiple Myeloma and as listed below.
- Progressive Disease (which requires 1 or more of the following)(A):
Increase of greater than or equal to 25% from the lowest response value (nadir) in any one or more of these parameters:
- Serum M-component (the absolute increase must be greater than or equal to 0.5 g/dL) (B) and/or
- Urine M-component and/or (the absolute increase must be greater than or equal to 200 mg/24 h)
- Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL.
- Bone marrow plasma cell percentage; the absolute percentage must be greater than or equal to 10%
- Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas (defined as 50% or greater increase in the sum of the products of the cross-diameters of target lesions)
- Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
- Relapse from complete remission (A)
- Defined as one or more of the following; must be attributable to myeloma:
- Reappearance of serum or urine M-protein by immunofixation or electrophoresis
- Development of greater than or equal to 5% plasma cells in the bone marrow
- Appearance of any other sign of progression (i.e., new plasmacytoma, lytic bone lesion, or hypercalcemia)
(A)All relapse and progression categories require two consecutive assessments made at any time before classification as relapse or disease progression and/or the institution of any new therapy.
(B)For progressive disease, serum M-component increases of greater than or equal to 1 gm/dL are sufficient to define progression if starting M-component is greater than or equal to 5 g/dL.
2.1.1.2 Other inclusion criteria:
- Greater than or equal to 18 years of age and less than or equal to age 73.
- Able to understand and sign the Informed Consent Document
Data sourced from ClinicalTrials.gov (NCT02215967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.