Clinical Trial Goal
To find out if CAR T cells in combination with lenalidomide is safe and works better than lenalidomide alone to treat multiple myeloma that is refractory after treatment with autologous BMT
You may be able to join this trial if you:
- Are 18 years old or older
- Have multiple myeloma that is refractory after treatment with autologous BMT
- Have had a autologous BMT within the last 3 months
- Do not have non-secretory multiple myeloma
- Have not had an allogeneic (cells from a donor) BMT or gene therapy
- 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.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
Lenalidomide is a drug that blocks growth of cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
Lenalidomide is a drug that blocks growth of cancer cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – lenalidomide
- Group 2 – lenalidomide plus ide-cel CAR T-cell therapy
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
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 two standard drugs:
- Cyclophosphamide - Group 2 only – Given as intravenous (IV) infusions
- Fludarabine - Group 2 only - Given as IV infusions
Then, the CAR T cells are given to you through an IV infusion.
You'll also get:
- Lenalidomide - A pill that you take by mouth
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 all of the drugs used in this trial.
Watch a video about CAR T-Cell Therapy
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Contacts
BMS Study Connect Contact Center www.BMSStudyConnect.com, 855-907-3286, Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
Locations
Sponsors
lead: Celgene, collaborator: Bristol-Myers Squibb
