A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis, BEAT-MS
This is a study for patients with relapsing multiple sclerosis (MS). This study will compare the duration of relapse-free survival in participants receiving best available treatment (BAT) or autologous stem cell transplant. Patients will be assigned by chance (randomly -- like the flip of a coin) to receive a stem cell transplant or a standard treatment for MS (alemtuzumab, natalizumab, ocrelizumab, cladribine, ofatumumab, or rituximab) chosen by their physician.
Stem cell transplant
1. Age 18 to 55 years, inclusive, at the time of the screening.
2. Diagnosis of MS
3. Highly active treatment-resistant relapsing MS
4. Candidacy for treatment with at least one of the following high efficacy disease-modifying treatments: natalizumab, alemtuzumab, ocrelizumab, and/or rituximab.
5. Cannot have had prior treatment with an investigational agent within 3 months
6. Cannot have evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C
7. Cannot have evidence of HIV infection
8. Cannot have the presence or history of clinically significant heart disease
9. Cannot have history of cancer, except adequately treated basal cell or squamous skin cancer, or carcinoma in situ of the cervix. Cancer for which the participant is judged to be cured by therapy completed at least 5 years prior to study entry may be considered on a case-by-case basis.
18 - 55
Healthy Volunteers Needed
Duration of Participation
Vijayshree Yadav, MD 503-494-3813
Levanto Schachter, DO 503-494-5186
Debbie A. Guess, B.S.N. 503-494-7651
Immune Tolerance Network