A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

Date Added
April 9th, 2026
PRO Number
Pro00149086
Researcher
Anthony Dominick

List of Studies

Keywords
Cancer
Summary

This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.

Institution
MUSC
Recruitment Contact
Thomas Hortman
8437929300
hortman@musc.edu

The Impact of Toxic Exposures on Vascular Autoantibodies in Lupus Associated Cardiovascular Disease

Date Added
April 10th, 2026
PRO Number
Pro00147299
Researcher
Helen Butler

List of Studies

Keywords
Cardiovascular, Lupus
Summary

The purpose of this study is to understand how exposure to harmful substances during military service may affect the health of Veterans with or without lupus. Lupus is an autoimmune disease that can increase the risk of cardiovascular problems.

We believe that Veterans who were exposed to toxic substances during their military service may develop more harmful antibodies that attack the lining of their blood vessels. These antibodies may contribute to poorer blood vessel and heart health, and could contribute to the development of lupus.

This study aims to improve our understanding of how toxic military exposures may increase the risk of blood vessel complications in Veterans with and without lupus. Ultimately, this research may help identify new ways to better prevent, monitor, or treat cardiovascular disease in this population.

Research procedures for this study will include:

1. The study team will check subject medical records to gather information about medical history and medications being taking. The study team may continue to follow updates in the medical record.
2. Subjects will be given a survey to assess military and occupational toxic inhalant exposures.
3. Subjects will have a brief physical examination during which vitals will be recorded (height, weight, heart rate, respiration, temperature). Women of childbearing ages will be asked for the date of their last menstrual cycle within the past 2 months.
4. Subjects will have blood pressure taken three times three minutes apart.
5. Subjects will then provide a urine sample. Urine collection will occur in a private restroom using a sterile container provided by the study team. For women of childbearing ages, a pregnancy dipstick test will be undertaken on urine to confirm subjects are not pregnant.
6. Subjects will undergo a blood draw where approximately 4 teaspoons of blood will be drawn.

Institution
MUSC
Recruitment Contact
Helen Butler
7046540686
butlehel@musc.edu

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS PRASINEZUMAB IN PARTICIPANTS WITH EARLY-STAGE PARKINSON'S DISEASE

Date Added
April 14th, 2026
PRO Number
Pro00149436
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Parkinsons
Summary

This research study is being done to see the effectiveness and safety of a new drug called prasinezumab as a possible treatment for Parkinson's Disease. It has not been approved by the Food and Drug Administration. Eligible participants will be randomly assigned to received either prasinezumab or placebo (an inactive substance) The drug or placebo is given as an intravenous infusion every 4 weeks. Participation in the study is expected to last approximately 3 years. There is a Screening period that will last up to six weeks and a study treatment period that can last 104 weeks. There are two options at the end of the study, 1. Safety follow-up 70 days after last dose or Option 2: Two years of Open label prasinezumab and safety follow-up 70 days after last dose. The Screening, Randomization and Treatment period, Year 1 is 19 visits and treatment period Year 2 is 17 visits. Each visit will last to 4 to 6 hours. The OLE Year 1 is 16 visits and OLE Year 2 is 15 visits, and each visit will last 4 to 6 hours.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
8437921115
bulgarino@musc.edu

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation

Date Added
April 14th, 2026
PRO Number
Pro00150050
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart, Surgery
Summary

This study is enrolling subjects with severe aortic regurgitation (when blood leaks back in the heart because the aortic valve does not close properly) into a randomized study. Typically valve replacement is performed to correct this condition. This study will compare a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to open heart aortic valve surgery (SAVR). the JeneValve Trilogy Heart Valve System is considered investigational meaning it has not been approved yet by the Food and Drug Administration (FDA). A TAVR procedure is done by accessing a large blood vessel at the top of your leg and delivering the new valve as opposed to open heart surgery. This study will randomize subjects in a 1 to 1 fashion to TAVR or SAVR. Randomized means assigned by chance, so you will have a 50% chance of being assigned to the TAVR group and a 50% chance of being assigned to the SAVR group. The SAVR group will have the aortic valve replacement done by open heart surgery using a commercially available device.

Participation in this study will last about 10 years and include 15 visits. Study related testing includes physical exam, echocardiograms (ultrasound test of the heart), electrocardiograms (recording of heart's electrical activity), 6 minute hall walk, bloodwork and a questionnaire.

There are risks including risks related to the procedure and to study testing. There may be no benefit but the information learned may help in treating others in the future.

Institution
MUSC
Recruitment Contact
Virginia Theodorof
843-876-9078
theodoro@musc.edu

Case-Control Study of a Novel Test for the Early Detection of Hepatocellular Carcinoma in at-risk Patients with Cirrhosis

Date Added
May 1st, 2026
PRO Number
Pro00149583
Researcher
Don Rockey

List of Studies


Keywords
Cancer, Liver
Summary

This study will enroll patients that were either diagnosed with hepatocellular cancer (HCC) in the past 6 weeks or have been diagnosed with cirrhosis but do not have HCC. Patients will have a blood sample collected to test if a new blood-based biomarker is accurate in the early detectection of HCC.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
(843)-876-8439
blanke@musc.edu

Evaluating the Feasibility of a Modular Transdiagnostic Intervention for Traumatic Bereavement

Date Added
May 5th, 2026
PRO Number
Pro00150639
Researcher
Jamison Bottomley

List of Studies

Keywords
Mental Health, Psychiatry
Summary

This study is testing a new therapy called GRIEF Approach (Grief Recovery with Individualized Evidence-Based Formulation) to help adults who have lost a loved one to a sudden or violent death, such as suicide, homicide, drug overdose, or car crash. Many people who experience this type of loss develop depression, post-traumatic stress, and/or prolonged grief, and current treatments often fail to address all of these symptoms together. GRIEF Approach is a flexible, individualized therapy that combines evidence-based strategies to address traumatic stress, grief, and depression within a single treatment. The primary goal of this study is not to test whether the therapy works, but to evaluate whether it is feasible and acceptable to patients and therapists. Participants will complete mood and symptom questionnaires at the start of the study, weekly during treatment, and one month after treatment ends. Participants will also provide feedback on their experience with the therapy through questionnaires and brief interviews. Findings from this study will be used to refine the treatment and study procedures in preparation for a larger clinical trial.

Institution
MUSC
Recruitment Contact
Jamison Bottomley
8436331850
bottomle@musc.edu

Neural and Behavioral Dynamics During Neurorehabilitation

Date Added
May 7th, 2026
PRO Number
Pro00149437
Researcher
Nathan Rowland

List of Studies


Keywords
Brain, Physical Therapy, Spinal Cord, Stroke, Stroke Recovery
Summary

This research study aims to better understand how the brain and body change during physical or occupational therapy after a neurologic injury or condition. Adults who are already receiving outpatient neurorehabilitation will be invited to participate while they complete their regular therapy sessions. During therapy, participants will wear a lightweight cap that measures brain activity and will be video recorded so researchers can analyze movement patterns using computer software. These recordings do not change therapy activities and are for research purposes only. The study does not involve new treatments, medications, or procedures beyond standard care. Information collected may help researchers understand why recovery differs between individuals and improve future rehabilitation approaches.

Institution
MUSC
Recruitment Contact
M S Zobaer
832-955-7191
zobaer@musc.edu

Developing at-home taVNS for neurorehabilitation in Parkinson's Disease

Date Added
May 19th, 2026
PRO Number
Pro00149153
Researcher
Daniel Lench

List of Studies

Keywords
Parkinsons
Summary

This study is designed to explore a new treatment option for motor symptoms in people with Parkinson's disease. Motor symptoms and gait disturbance for Parkinson's are often disabling and can increase risk of falls and requce quality of life. We are testing whether a non-invasive brain stimulation technique called transcutaneous auricular vagus nerve stimulation (taVNS) is tolerable, acceptable and can be administered at-home and used to improve symptoms of Parkinson's disease. TaVNS delivers electrical impulses through the skin of the ear to the vagus nerve which research has shown modulates brain activity. The purpose of this research is to see whether this treatment approach is feasible, tolerable and and potentially effective at treating the symptoms of Parkinson's disease. If successful, this research study will hopefully lead to a larger study in the future where the efficacy of the treatments can be studied.

Institution
MUSC
Recruitment Contact
Emily Laramie
8437923873
laramie@musc.edu

An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

Date Added
June 9th, 2026
PRO Number
Pro00150609
Researcher
Charlie Strange

List of Studies


Keywords
Lung, Pulmonary, Rare Diseases
Summary

This study is designed to evaluate a new therapy formulation for Alpha-1 Antitrypsin Deficiency (AATD). AATD is an inherited condition in which a person has low blood levels of a protein known as alpha-1 protease inhibitor (called Alpha1-PI). AATD causes an increased risk of chronic obstructive pulmonary disease (COPD) in the form of emphysema (long term lung disease) and, less frequently, other diseases.

This study is being conducted to evaluate the safety and tolerability of 2 different doses of Alpha-1 drugs (Alpha-1 15% and Liquid Alpha1-PI) in participants with AATD. Participants will be placed into one of two groups. Each group will receive both drugs, but different doses of each, at different points in the treatment period (8 Weekly IV infusions of Liquid Alpha1-PI 60 mg/kg followed by 8 Weekly SC (subcutaneous) infusions Alpha1-PI 90 mg/kg OR 8 Weekly IV infusions of Liquid Alpha1-PI 120 mg/kg followed by 8 Weekly SC (subcutaneous) infusions Alpha1-PI 180 mg/kg).

This is an "open label" study, meaning participants and the study staff know which dose of study drug participants receive. The study will last up to 161 days (23 weeks). Many visits are able to be conducted through home health care, lessening the need to come into the clinic.

Alpha-1 15% is an investigational product, meaning it is not approved by the U.S. Food and Drug Administration (FDA). The other drug in this study is Liquid Alpha1-PI (licensed as Prolastin®-C Liquid) and is an FDA approved treatment for adults with emphysema due to AATD. However, it is only approved for the recommended dose of 60 mg/kg. This study includes both the FDA approved 60mg/kg of Liquid Alpha1-PI and an experimental dose of 120 mg/kg that is not FDA approved. Alpha-1 15% is given as an injection under the skin and Liquid Alpha1-PI is given as an infusion into the veins.

Institution
MUSC
Recruitment Contact
Bridger Scoggins
8284485234
scoggibr@musc.edu

Building Optimal Strategies to Enhance Parent and Infant Wellbeing in CHD

Date Added
June 24th, 2026
PRO Number
Pro00150704
Researcher
Eric Graham

List of Studies


Keywords
Pediatrics
Summary

The BOND study is being done to find new ways to support mothers and their babies after CHD diagnosis. The BOND study has two parts. One part, HeartGPS, will look at how a new emotional support program may help mothers adjust to their baby's diagnosis during pregnancy and after birth. The second part, Direct Breastfeeding will look at how to support mothers who breastfeed. Both parts will look at how these new support programs may improve the well-being of mothers and the bond between mother and baby.

Institution
MUSC
Recruitment Contact
Terry Headley
843.494.3796
headleyt@musc.edu



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