IRB Study Number 19-1204
Status Recruiting
Phase Not Applicable
Location U Building - Mellen Center
Institute Neurological Institute
Description
Participants with treatment-resistant relapsing MS will be randomized 1:1 to compare efficacy, safety, immunologic effects, and cost-effectiveness of myeloblative and immunoablative therapy followed by autologous hematopoietic stem cell transplant (AHSCT) versus best available therapy (BAT) over 72 months.
AHSCT
- Mobilization of peripheral blood stem cells (PBSCs) with cyclophosphamide, filgrastim, and dexamethasone
- PBSC graft collection by leukapheresis
- Conditioning with carmustine, etoposide, cytarabine, melphalan (BEAM), and rabbit antithymocyte globulin (rATG)
- PBSC graft infusion
BAT
- Treatment with any of the following BAT agents as determined by the site investigator: cladribine, natalizumab, alemtuzumab, ocrelizumab, ublituximab, or rituximab
Inclusion Criteria
- 18-55 years
- Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis (RRMS or SPMS)
- EDSS score of 6 or lower
- At least 2 episodes of disease activity in past 36 months, one of which must have occurred in last 12 months. At least one episode must be a clinical MS relapse (the other may be a clinical MS relapse or MRI activity), and at least one episode must have occurred while on an oral DMT or monoclonal antibody
Exclusion Criteria
- Diagnosis of primary progressive MS
- Prior history of AHSCT
- Presence of any concomitant medical condition the investigator deems incompatible with trial participation
*Other protocol defined inclusion/exclusion criteria may apply.
