Clinical Trial Goal
To find out if autologous BMT is safe and works well to treat MS compared to standard of care
You may be able to join this trial if you:
- Are 18 - 55 years old
- Have MS that is relapsing:
- Relapse remitting MS (RRMS)
- Secondary progressive MS (SPMS)
- Have had at least 2 different treatments not work in the last 2 years
- Are able to take at least one of the following drugs:
- Alemtuzumab
- Cladribine
- Natalizumab
- Ocrelizumab
- Ofatumumab
- Rituximab
- Do not have primary progressive MS (PPMS)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Alemtuzumab is a monoclonal antibody that targets CD52 on certain cells.
Anti-thymocyte globulin (ATG) is a standard drug used to prevent graft-versus-host disease (GVHD).
Carmustine, cyclophosphamide, cytarabine, etoposide, and melphalan are chemotherapy (chemo) drugs that help prepare your body for BMT.
Filgrastim is a drug that helps your white blood cells grow.
Mesna is a drug that helps protect your bladder from the side effects of chemo.
Natalizumab is a monoclonal antibody that targets α4-integrin on certain cells.
Ocrelizumab and rituximab are monoclonal antibodies that target CD20 on certain cells.
Ublituximab is a monoclonal antibody that targets CD20 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told which group you’re in:
Anti-thymocyte globulin (ATG) is a standard drug used to prevent graft-versus-host disease (GVHD).
Carmustine, cyclophosphamide, cytarabine, etoposide, and melphalan are chemotherapy (chemo) drugs that help prepare your body for BMT.
Filgrastim is a drug that helps your white blood cells grow.
Mesna is a drug that helps protect your bladder from the side effects of chemo.
Natalizumab is a monoclonal antibody that targets α4-integrin on certain cells.
Ocrelizumab and rituximab are monoclonal antibodies that target CD20 on certain cells.
Ublituximab is a monoclonal antibody that targets CD20 on certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told which group you’re in:
- Group 1 – Standard of care
- Group 2 – Autologous BMT
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.
If you’re in Group 1, you’ll get standard of care treatment for relapsing MS. The clinical trial doctor will decide which treatment you get. This may include:
- Alemtuzumab
- Cladribine
- Natalizumab
- Ocrelizumab
- Ofatumumab
- Rituximab
- Ublituximab
If you’re in Group 2, you’ll get an autologous BMT.
First, you’ll get:
- Cyclophosphamide – Given as intravenous (IV) infusions
- Dexamethasone – A pill that you take by mouth
- Filgrastim – Given as shots under your skin
- Mesna – Given as IV infusions
Then, you’ll have apheresis, a process to collect, separate and save your blood-forming cells.
Then, in the days before BMT, you’ll get treatment to prepare your body. You’ll get:
- ATG – Given as IV infusions
- Carmustine – Given as IV infusions
- Cytarabine – Given as IV infusions
- Etoposide – Given as IV infusions
- Melphalan – Given as IV infusions
Then, on transplant day, you’ll get your own blood-forming cells, given as an IV infusion.
You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for 6 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.
Locations
Sponsors
collaborator: Immune Tolerance Network (ITN), collaborator: Blood and Marrow Transplant Clinical Trials Network, collaborator: PPD Development, LP, collaborator: Rho Federal Systems Division, Inc., lead: National Institute of Allergy and Infectious Diseases (NIAID)
