Administration of Tumor-Associated Antigen (TAA) Specific T-Lymphocytes to Patients with Active Myeloma (TACTAM) (H-35626) (H-35626)

This study is for patients that have a cancer called Multiple Myeloma, monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM). MGUS and SM have tumor cells that possess nearly identical properties to the cancer cells seen in patients with multiple myeloma.

We would like to target proteins that are expressed by these cells using the patient's own immune cells known as T lymphocytes. This research study uses special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes (CTLs), a new experimental therapy.

The proteins that investigators are targeting in this study are called tumor associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They either do not show or show up in low quantities on normal human cells. In this study we target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different protocol, patients have been treated and so far this treatment has shown to be safe.

Investigators now want to try this treatment in patients with multiple myeloma or if we can arrest the progression of the patient's condition condition (described above) to multiple myeloma.

These TAA-specific CTLs are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to find the largest safe dose of TAA-specific CTLs, to learn what the side effects are, and to see whether this therapy might help patients with multiple myeloma monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SM)

Enrollment is limited to GROUP C only.

Age requirements: 18 years or older

More information about this study can be found on clinicaltrials.gov.

NCT#/ClinicalTrials.gov ID: NCT02291848