Clinical Trial Goal
To find out if BMS-986453 is safe and works well to treat newly diagnosed multiple myeloma
You may be able to join this trial if you:
- Are 18 years old or older
- Have newly diagnosed multiple myeloma
- Do not have any of the following:
- Amyloidosis
- Plasma cell leukemia
- POEMS syndrome
- Waldenstrom's macroglobulinemia
- Are not able to get an autologous (your own cells) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
BMS-986453 is a type of CAR T-cell therapy that targets BCMA and GPRC5D on cancer cells.
Cyclophosphamide and fludarabine are drugs that block the growth of cancer cells.
To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
BMS-986453 is a type of CAR T-cell therapy that targets BCMA and GPRC5D on cancer cells.
Cyclophosphamide and fludarabine are drugs that block the growth of cancer cells.
To make CAR T cells, T cells are collected from you by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions
- Fludarabine – Given as IV infusions
Then, the CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.
The clinical trial doctors will watch you closely during treatment. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.
The Food and Drug Administration (FDA) has approved cyclophosphamide and fludarabine.. The FDA has not yet approved BMS-986453.
Watch a video about CAR T-Cell Therapy
Contacts
Susan Bal, MD, (205) 934-7645, susanbal@uabmc.edu
Margaret Thomas, MPH, margaretathomas@uabmc.edu
Locations
University of Alabama at BirminghamRECRUITING
Birmingham, Alabama
Contacts:
- Susan Bal, MD, 2059347645, susanbal@uabmc.edu
- Luciano J Costa, MD, PhD, ljcosta@uabmc.edu
Sponsors
collaborator: Bristol-Myers Squibb, lead: Susan Bal
