IRB #

STUDY00020210

Title

A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis, BEAT-MS

Principal Investigator

Vijayshree Yadav

Study Purpose

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, or rituximab) chosen by their physician.

Medical Condition(s)

Multiple Sclerosis
Relapsing MS
Stem cell transplant
Alemtuzumab
Campath
Natalizumab
Tysabri
Ocrelizumab
Ocrevus
Rituximab
Rituxan

Eligibility Criteria

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.

Age Range

18 - 55

Healthy Volunteers Needed

No

Duration of Participation

6 years.

Minors Included

No

Contact

Vijayshree Yadav, MD 503-494-3813
Levanto Schachter, DO 503-494-5186
Debbie A. Guess, B.S.N. 503-494-7651

Sponsor

Immune Tolerance Network

Recruitment End

11/01/2022

Compensation Provided

No


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