Your session is about to expire
← Back to Search
Stem Cell Transplant
Stem Cell Transplant vs Best Available Therapy for Multiple Sclerosis (BEAT-MS Trial)
Phase 3
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T2 abnormalities on brain Magnetic Resonance Imaging (MRI) that fulfill the 2017 McDonald MRI criteria for dissemination in space
Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations, ≥ 14 days prior to randomization (Day 0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit pre-r up to 72 months (6 years)
Awards & highlights
BEAT-MS Trial Summary
This trial is testing whether AHSCT is better than BAT for treating people with MS who have not responded to other treatments. 156 people will be randomly assigned to either AHSCT or BAT, and followed for 72 months.
Who is the study for?
This trial is for adults aged 18-55 with treatment-resistant relapsing Multiple Sclerosis (MS), as per the McDonald Criteria, who've had at least two episodes of disease activity in the past three years despite treatment. Participants must have an EDSS score ≤6.0, be vaccinated against COVID-19 and varicella zoster, and agree to contraception use.Check my eligibility
What is being tested?
The BEAT-MS trial compares Autologous Hematopoietic Stem Cell Transplantation (AHSCT) with Best Available Therapy (BAT) for MS that hasn't responded well to other treatments. It's a blinded study where participants are randomly assigned to one of these strategies in equal numbers.See study design
What are the potential side effects?
Potential side effects from AHSCT may include infection risks due to immune system suppression, reactions related to stem cell infusion, and infertility. BAT side effects vary depending on the specific therapy used but can include flu-like symptoms, injection site reactions, and increased risk of infections.
BEAT-MS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain MRI shows changes that meet specific criteria for a diagnosis.
Select...
I completed my COVID-19 vaccination series more than 14 days ago.
Select...
I have been diagnosed with Multiple Sclerosis according to the latest criteria.
Select...
My disability level allows me to walk at least 100 meters without aid or rest.
Select...
My MS worsened despite taking approved medication for over a month.
Select...
I am between 18 and 55 years old.
Select...
My brain MRI shows specific changes that meet certain criteria for a diagnosis.
Select...
I can walk with a cane for 100 meters without help.
Select...
My condition has worsened or shown activity in the last year.
Select...
I am a candidate for high efficacy MS treatments like cladribine or natalizumab.
Select...
My MS has worsened twice or more in the last 3 years despite treatment.
BEAT-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from visit pre-r up to 72 months (6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit pre-r up to 72 months (6 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Multiple Sclerosis (MS) Relapse-Free Survival
Secondary outcome measures
Change in Serum Neurofilament Light Chain (NfL) Concentration
Number of Multiple Sclerosis (MS) Relapses Per Year
Proportion of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Recipients Who Experience Primary or Secondary Graft Failure
+9 moreSide effects data
From 2022 Phase 3 trial • 665 Patients • NCT0056756784%
58300-Neutrophil count decreased
70%
65800-Platelet count decreased
20%
43100-Hypokalemia
18%
44800-Infections and infestations - Other specify
18%
33300-Febrile neutropenia
17%
88500-White blood cell decreased
13%
13200-Anemia
9%
55600-Mucositis oral
7%
42700-Hypocalcemia
7%
13500-Anorexia
7%
11600-Alanine aminotransferase increased
7%
41400-Hyperglycemia
6%
15000-Aspartate aminotransferase increased
6%
43300-Hyponatremia
6%
73700-Sepsis
6%
53700-Lymphocyte count decreased
4%
25700-Diarrhea
3%
65900-Pleural effusion
3%
57600-Nausea
3%
37500-GGT increased
3%
41600-Hyperkalemia
3%
10300-Abdominal pain
3%
20500-Catheter related infection
3%
59700-Oral pain
2%
38900-Hearing impaired
2%
43900-Hypoxia
2%
17200-Blood and lymphatic system disorders - Other specify
2%
14900-Ascites
2%
75700-Small intestinal obstruction
2%
87900-Vomiting
2%
43600-Hypotension
1%
66300-Pneumonitis
1%
42600-Hypoalbuminemia
1%
26600-Duodenal obstruction
1%
69700-Rash maculo-papular
1%
23000-Confusion
1%
71500-Respiratory failure
1%
34000-Fibrinogen decreased
1%
45800-INR increased
1%
73900-Serum amylase increased
1%
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify
1%
56600-Myelitis
1%
75600-Small intestinal mucositis
1%
66800-Postoperative hemorrhage
1%
43500-Hypophosphatemia
1%
37300-Generalized muscle weakness
1%
81200-Treatment related secondary malignancy
1%
31200-Esophagitis
1%
83100-Urinary tract infection
1%
24100-Creatinine increased
1%
11100-Acute kidney injury
1%
62600-Pelvic pain
1%
65300-Pharyngolaryngeal pain
1%
31900-Eye disorders - Other specify
1%
10900-Activated partial thromboplastin time prolonged
1%
11800-Alkaline phosphatase increased
1%
42500-Hyperuricemia
1%
17400-Blood bilirubin increased
1%
63100-Pericardial effusion
1%
72700-Right ventricular dysfunction
1%
37200-General disorders and administration site conditions - Other specify
1%
40000-Hepatic failure
1%
88200-Weight gain
1%
41300-Hypercalcemia
1%
54900-Metabolism and nutrition disorders - Other specify
1%
71000-Renal and urinary disorders - Other specify
1%
69000-Pulmonary hypertension
1%
20100-Cardiac disorders - Other specify
1%
22100-Colitis
1%
44200-Ileal obstruction
1%
81900-Typhlitis
1%
33900-Fever
1%
35500-Gallbladder pain
1%
40600-Hepatobiliary disorders - Other specify
1%
66500-Portal hypertension
1%
12000-Allergic reaction
1%
13100-Anaphylaxis
1%
44700-Immune system disorders - Other specify
1%
13400-Anorectal infection
1%
25600-Device related infection
1%
29500-Enterocolitis infectious
1%
53100-Lung infection
1%
62500-Pelvic infection
1%
75200-Skin infection
1%
82300-Upper respiratory infection
1%
14500-Arterial injury
1%
15300-Ataxia
1%
38800-Headache
1%
63900-Peripheral motor neuropathy
1%
11300-Adult respiratory distress syndrome
1%
29700-Epistaxis
1%
78100-Stridor
1%
68400-Pruritus
1%
51700-Left ventricular systolic dysfunction
1%
27800-Dyspnea
1%
58100-Nervous system disorders - Other specify
1%
29000-Encephalopathy
1%
42100-Hypertension
1%
24700-Dehydration
1%
43200-Hypomagnesemia
1%
31800-Extrapyramidal disorder
1%
52600-Lipase increased
1%
10700-Acidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tandem HST (CEM), Randomly Assigned
Single HST (CEM)
Not Assigned
BEAT-MS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AHSCTExperimental Treatment1 Intervention
AHSCT: Myeloablative and Immunoablative therapy followed by Autologous Hematopoietic Stem Cell Transplantation
Participants will undergo:
Mobilization and graft collection: mobilization of peripheral blood stem cells (PBSC) with cyclophosphamide, filgrastim, and dexamethasone. The autologous graft will be collected by leukapheresis and cryopreserved.
Conditioning: high dose myeloablative and immunoablative conditioning with a six-day BEAM chemotherapy and rabbit anti-thymocyte globulin regimen will be initiated ≥30 days after cyclophosphamide mobilization.
Autologous cryopreserved graft infusion: the cryopreserved peripheral blood stem cells (PBSC) graft will be thawed and infused the day following completion of the conditioning regimen. Each bag will be thawed and infused according to institutional standards consistent with the Foundation for the Accreditation of Cellular Therapy (FACT) guidelines. Participants will receive prednisone following graft infusion.
Group II: Best Available Therapy (BAT)Active Control1 Intervention
Participants randomized to BAT: Best available therapy will be selected by the Site Investigator from: Cladribine (Mavenclad®), natalizumab (Tysabri®), alemtuzumab (Campath®, Lemtrada®), ocrelizumab (Ocrevus®), ublituximab (BRIUMVI™), rituximab (Rituxan®), or ofatumumab (Arzerra®) (after approval by the FDA for relapsing MS).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,272 Previous Clinical Trials
5,483,764 Total Patients Enrolled
16 Trials studying Multiple Sclerosis
4,138 Patients Enrolled for Multiple Sclerosis
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,774 Total Patients Enrolled
5 Trials studying Multiple Sclerosis
342 Patients Enrolled for Multiple Sclerosis
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
13,826 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PML based on brain MRI or CSF tests.I have a history of low blood cell counts due to MDS.My brain MRI shows changes that meet specific criteria for a diagnosis.I have had a solid organ transplant in the past.You have unexplained low or high levels of blood cells.I started a specific drug treatment between my second visit and the day I was randomized in the study.I have a history of sickle cell anemia or similar blood disorders.I am willing to switch to MARINOL® if needed for the study.I have had a stem cell transplant before.My insurance covers MS treatment with a specific drug.Your heart's pumping ability is less than 50%.I currently have an active stomach ulcer.I completed my COVID-19 vaccination series more than 14 days ago.I have had an acute MS flare-up or steroid treatment within the last month.I have been diagnosed with Multiple Sclerosis according to the latest criteria.You have a positive test for tuberculosis (TB).You are not willing to accept or understand that you may become unable to have children as a result of the treatment.The site neurology investigator needs to see a detailed report or images from an MRI.I have or had a serious autoimmune disease that needed treatment.I have had at least one MS flare-up and another symptom or flare-up at a different time.My diabetes is not well-managed, with an HbA1c level over 8%.You tested positive for COVID-19 within 14 days before starting the study.I do not have any active infections, including viral, bacterial, or fungal.My disability level allows me to walk at least 100 meters without aid or rest.I am immune to chickenpox either through vaccination or past infection.My MS worsened despite taking approved medication for over a month.I haven't been hospitalized for infections or received IV/IM infection treatments in the last 30 days, or I have clearance from an Infectious Disease specialist.I am between 18 and 55 years old.My brain MRI shows specific changes that meet certain criteria for a diagnosis.My kidney function is reduced with an eGFR below 60.I haven't taken experimental drugs recently, except for FDA-approved COVID-19 treatments.I have been diagnosed with primary progressive MS.I have a history of neuromyelitis optica or MOG antibody disease.I can walk with a cane for 100 meters without help.You have been diagnosed with HIV.I have or had liver cirrhosis.My condition has worsened or shown activity in the last year.I have had cancer before, but it was either skin cancer treated successfully or early-stage cervical cancer.I have or had a neurological disorder.You have had a bad reaction to proteins from rabbits or Escherichia coli bacteria.I have not received any live vaccines in the last 6 weeks.Your lung function test shows that you can't breathe out a certain amount of air.Your lung function test result shows that your ability to transfer oxygen from your lungs to your blood is less than 70% of what is expected.You have been diagnosed with multiple sclerosis using the 2017 McDonald Criteria.I am a candidate for high efficacy MS treatments like cladribine or natalizumab.My liver condition meets specific health criteria.You have metal or electronic implants in your body that would prevent you from getting an MRI with a contrast agent.You have had hepatitis B or hepatitis C in the past, even if it has been treated.I have had a stroke or similar brain blood flow problem.My MS has worsened twice or more in the last 3 years despite treatment.I have or had a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: AHSCT
- Group 2: Best Available Therapy (BAT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total pool of people enrolled in this experiment?
"In order to properly conduct this study, 156 patients that fit the inclusion criteria must participate. These willing individuals can visit either the Multiple sclerosis Center at Northwest Hospital in Seattle or Mayo Clinic in Rochester."
Answered by AI
Is this a clinical study that is still enrolling new test subjects?
"Yes, this trial is currently looking for volunteers according to the most recent information available on clinicaltrials.gov. The first posting was on December 19th, 2019 with the last update being made on July 7th, 2022."
Answered by AI
What are the chief reasons that people receive Autologous Hematopoietic Stem Cell Transplantation treatment?
"Autologous Hematopoietic Stem Cell Transplantation is a procedure that is used to treat chronic lymphocytic leukemia. This intervention can also be effective for diffuse large b-cell lymphoma (dlbcl), b-cell lymphomas, polyangium."
Answered by AI
Has the Autologous Hematopoietic Stem Cell Transplantation been cleared by the FDA?
"Autologous Hematopoietic Stem Cell Transplantation is considered safe, as it has reached Phase 3 in clinical trials. This means that the treatment has some data supporting efficacy and multiple rounds of data supporting safety."
Answered by AI
Are there similar procedures to Autologous Hematopoietic Stem Cell Transplantation that have been studied before?
"527 clinical trials are currently being conducted to study the efficacy of Autologous Hematopoietic Stem Cell Transplantation. 120 of those 527 trials are in Phase 3. Many of these trials originate from Philadelphia, but there are a total of 17970 locations running active trials for this treatment worldwide."
Answered by AI
Does this research include patients that are senior citizens?
"The age requirements for this study are that potential participants must be over 18 but under 55 years old."
Answered by AI
Is this study taking place in more than one state in America?
"There are a number of hospitals and medical centres across the United States of America that are taking part in this study. A few notable locations include the Multiple sclerosis Center at Northwest Hospital in Seattle, Washington, Mayo Clinic in Rochester, Minnesota, and John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis in Palo Alto, California."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
New Jersey
Other
New York
How old are they?
18 - 65
What site did they apply to?
University of Minnesota Multiple Sclerosis Center
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai
Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
Trying to find something to help with the progression of my MS. copaxone, gylenia, lemtrada All those and nothing has helped. It could change my life, I CAN STAND ROAUUUgh!!! Give me chance.
PatientReceived 2+ prior treatments
I was diagnosed with RRMS on 10/24/2018. Shortly after my diagnosis, I began Ocrevus treatments. While I have not had any changes on my MRI's, I have progressed to SPMS. I am hopeful that this trial will help me to stop or slow down disease progression.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center: < 24 hours
Average response time
- < 1 Day
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger