NCT04047628 - Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) | Biotech Hunter

Enrollment

156

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2029

Conditions

Relapsing Multiple SclerosisRelapsing Remitting Multiple SclerosisSecondary Progressive Multiple Sclerosis

Interventions

PROCEDURE

Autologous 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."

BIOLOGICAL

Best Available Therapy (BAT)

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

Trial Locations (20)

10029

RECRUITING

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai, New York

14620

NOT_YET_RECRUITING

Rochester Multiple Sclerosis Center, University of Rochester, Rochester

19104

RECRUITING

Penn Comprehensive MS Center, Hospital of the University of Pennsylvania, Philadelphia

23219

RECRUITING

Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center, Richmond

27710

ACTIVE_NOT_RECRUITING

Duke University Medical Center, Durham

44195

RECRUITING

Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland

45219

RECRUITING

University of Cincinnati (UC) Waddell Center for Multiple Sclerosis, Cincinnati

55455

ACTIVE_NOT_RECRUITING

University of Minnesota Multiple Sclerosis Center, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

60208

RECRUITING

Northwestern University, Evanston

63110

RECRUITING

John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis, St Louis

75390

RECRUITING

University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology, Dallas

77030

RECRUITING

Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center, Houston

80045

RECRUITING

Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine, Aurora

94304

RECRUITING

Stanford Multiple Sclerosis Center, Palo Alto

97239

RECRUITING

Multiple Sclerosis Center, Oregon Health & Science University, Portland

98109

RECRUITING

Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle

98122

RECRUITING

Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle

98133

RECRUITING

Multiple Sclerosis Center at Northwest Hospital, Seattle

01655

RECRUITING

University of Massachusetts Memorial Medical Center, Worcester