RecruitingPhase 3NCT04047628

Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)

A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

156 participants

Start Date

Dec 19, 2019

Study Type

INTERVENTIONAL

Conditions

Relapsing Multiple Sclerosis Relapsing Remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Summary

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).

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two treatment approaches for people with highly active, treatment-resistant multiple sclerosis (MS): the best currently available drug therapy versus an autologous stem cell transplant — a procedure where your own immune cells are collected, the immune system is 'reset' with chemotherapy, and then the cells are returned to rebuild a healthier immune system. **You may be eligible if...** - You are 18-55 years old with a confirmed diagnosis of relapsing MS (multiple sclerosis) - You have highly active MS that has continued to worsen despite treatment with at least one approved MS drug - You have had at least 2 episodes of disease activity (relapses or new MRI lesions) in the past 3 years - Your disability score (EDSS) is 6.0 or lower (meaning you can walk, possibly with aid) **You may NOT be eligible if...** - You have progressive MS (not relapsing) - You have severe other medical conditions (heart, liver, kidney problems) - You have active infections like HIV or hepatitis - You are pregnant or planning pregnancy during the trial - You have had prior stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAutologous Hematopoietic Stem Cell Transplantation

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.

BIOLOGICALBest Available Therapy (BAT)

Disease-modifying therapy (DMT) selected by the Site Investigator from the below: * cladribine * natalizumab * alemtuzumab * ocrelizumab, * rituximab, * ofatumumab, or * ublituximab

Locations(22)

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

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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