Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) • ClinicalTrials.gov ID: NCT04047628
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This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio. All participants will be followed for 72 months after randomization (Day 0, Visit 0).
Interventions
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Autologous Hematopoietic Stem Cell Transplantation
(Procedure)
1. PBSC mobilization \& collection regimen per protocol/ institutional standards includes: intravenous cyclophosphamide (Cytoxan®), 4 grams/m\^2); intravenous mesna (Mesnex®),a total delivery of 4 grams/m\^2); oral dexamethasone, 10 mg dose, four times daily); subcutaneous filgrastim,10 mcg/kg/day until leukapheresis goal is completed; and CD34+ peripheral blood stem cells collection by leukapheresis. 2. Conditioning per protocol\& institutional standards: * 6-day BEAM (e.g. Carmustine (BCNU), Etoposide (VP-16), Cytarbine (Ara-C), and Melphalan) chemotherapy protocol and, * rabbit anti-thymocyte globulin (rATG) 2.5 mg/kg/day x2 3. Autologous cryopreserved graft infusion: The target Cluster of Differentiation (CD)34+ cell dose for infusion is 5 x 10\^6 CD34+ cells/kg (minimum 4 x 10\^6 CD34+ cells/kg; maximum 7.5 x 10\^6 CD34+ cells/kg). For 1\&2 above: Ideal body weight (IBW) versus Actual Body Weight (ABW) are applicable.
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Best Available Therapy (BAT)
(Biological)
Disease-modifying therapy (DMT) selected by the Site Investigator from the below: * cladribine * natalizumab * alemtuzumab * ocrelizumab, * rituximab, * ofatumumab, or * ublituximab
Eligibility criteria
Conditions
Locations
- Stanford Multiple Sclerosis Center — Palo Alto, California, United States
- Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine — Aurora, Colorado, United States
- Northwestern University — Evanston, Illinois, United States
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
- Henry Ford Neuroscience Institute — Detroit, Michigan, United States
- University of Minnesota Multiple Sclerosis Center — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
- Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai — New York, New York, United States
- Rochester Multiple Sclerosis Center, University of Rochester — Rochester, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Cincinnati (UC) Waddell Center for Multiple Sclerosis — Cincinnati, Ohio, United States
- Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic — Cleveland, Ohio, United States
- Multiple Sclerosis Center, Oregon Health & Science University — Portland, Oregon, United States
- Penn Comprehensive MS Center, Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology — Dallas, Texas, United States
- Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center — Houston, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center — Richmond, Virginia, United States
- Clinical Research Division, Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- Multiple Sclerosis Center, Swedish Neuroscience Institute — Seattle, Washington, United States
- Multiple Sclerosis Center at Northwest Hospital — Seattle, Washington, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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