Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Date Added
September 28th, 2021
PRO Number
Pro00115401
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is lenalidomide and dexamethasone in combination with bortezomib or daratumumab. This approach is approved by the Food and Drug Administration (FDA). The purpose of this study is to see if patients who have a small amount of cancer left after initial treatment (called minimal residual disease (MRD)), could benefit from adding a new drug to the usual treatment. The study approach, using a combination of four drugs, is investigational and not approved by the FDA. Patients can expect to be on this study for up to 2 years. Patients will then be followed by their doctor for up to 15 years after completion of the study or until disease progression..

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Date Added
January 11th, 2022
PRO Number
Pro00116527
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Cancer/Myeloma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with multiple myeloma. The investigational drug in this study is idecabtagene vicleucel (ide-cel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to have about 8 clinic visits and to be in this study for up to 3 months after receiving the study drug and in follow up for up to 15 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Randomized Crossover Trial of Bright Light Therapy in Irritable Bowel Syndrome

Date Added
August 20th, 2024
PRO Number
Pro00138575
Researcher
Caitlin Green

List of Studies


Keywords
Stomach
Summary

The purpose of this research study is to assess whether morning bright light therapy using a wearable glasses device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright therapy will be administrated through a safe-wearable device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

Institution
MUSC
Recruitment Contact
Keaveny (Katy) Donovan
8437927974
donova@musc.edu

M22-574: Phase 3 ABBV-383 vs Standard Available Treatment in Subjects with RRMM with at Least 2 Prior Lines of Therapies

Date Added
December 6th, 2024
PRO Number
Pro00136949
Researcher
Kimberly Green

List of Studies

Keywords
Cancer
Summary

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 2 Arms; Arm A (Parts 1 and 2) and Arm B. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. Around 120 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 30 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease.

Date Added
December 27th, 2024
PRO Number
Pro00140678
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for participants who have moderate or severe chronic graft-versus-host disease (cGVHD). cGVHD is a condition in which the healthy transplanted (graft) stem cells see the recipient's (host) cells as foreign and start to destroy them.
This Study is being done to learn the effects of the drug INCA034176 (also known as axatilimab) in combination with corticosteroids.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9300
salzers@MUSC.edu

Deprescribing Decision-Making using Machine Learning Individualized Treatment Rules to Improve CNS Polypharmacy - Aim 1

Date Added
March 7th, 2025
PRO Number
Pro00142274
Researcher
Jihad Obeid

List of Studies


Keywords
Non-interventional
Summary

The primary aim is to construct individualized treatment rule (ITR) models that predict optimal medication selection for deprescribing to maximize potential benefits and reduce harms to patients. To address this aim, we will collect retrospective EHR data for individuals over age 65 from three participating sites (Duke, Vanderbilt, and Medical University of South Carolina) and link this with medication dispensing and insurance claims data from the Centers for Medicare and Medicaid Services(CMS). We will apply causal inference methodology and supervised and unsupervised machine learning algorithms to predict both the benefits (reduced falls, cognitive disorders, hospitalizations) and potential
harms (adverse drug withdrawal events) of medication discontinuation. These predictions will be specific to individual patients and various central nervous system (CNS)-acting medication classes. The resulting machine learning models will be integrated into ITR models which will, in turn, support clinical practice by
recommending the medication class most likely to provide benefits, factoring in individual patient characteristics.

Institution
MUSC
Recruitment Contact
Alexandria Green
843-792-7011
Greealex@musc.edu

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Date Added
October 7th, 2025
PRO Number
Pro00146363
Researcher
Jason Newman

List of Studies

Keywords
Cancer
Summary

This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis

Date Added
February 11th, 2026
PRO Number
Pro00144745
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.

NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.

NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.

Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.

Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.

This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.

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



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