The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.
The aim of this study is to demonstrate the bioequivalence of DOXIL/CAELYX, 40 mg/m2 (IV infusion over 90 minutes) between two manufacturing facilities. According to the Food and Drug Administration (FDA), two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. Any abnormalities of the safety endpoints (Clinical Laboratory Test, Electrocardiogram, Left Ventricular Ejection Fraction, Physical Examination) will be captured as Adverse Events.
Up to 30% of patients with newly diagnosed/suspected myeloma cannot undergo or do not tolerate whole body MRI (WB-MRI). A number of factors may be contributory. First, WB-MRI protocols can take in excess of 1 hour. Patients must remain still within a narrow bore scanner with multiple MRI coils that can be claustrophobic. Second, there is significant acoustic noise that can be heard despite the use of ear protection. Third, 80% of patients will experience bone pain or fracture at some point during their illness, affecting their comfort within the scanner. Fourth, patients also have higher anxiety. One review reported up to 30% of...
Investigators designed the single-center, prospective real-world based clinical study with the aim of applying the standardized geriatric assessment system IMWG-FS internationally for dynamic frailty assessment of elderly newly diagnosed multiple myeloma(NDMM), guiding therapeutic decision based on their fit/frail status (fit → intensive; frail → mild), to observe their treatment tolerance, treatment related adverse events(TRAE), treatment discontinued(TD), and survival(progression survivaland overall survival).
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications. Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease. This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells. The main...
In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.
This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.
Patients with monoclonal gammopathies either benign or malignant may develop inflammatory symptoms such as Schnitzler syndrome. We proposed to name those cases as monoclonal gammopathy of inflammatory significance, or MGIS. The aim of the study is to search for inflammatory pathway that may be activated in case MGIS and to search if the genetic of tumoral cell could explain those activations.
All4Cure is partnering with community oncology practices participating in the Quality Cancer Care Alliance (QCCA) and Exigent Research to develop a clinical pathway that standardizes the evaluation, treatment and ongoing management of patients with newly diagnosed multiple myeloma who wish to achieve and maintain MRD negativity. This is a longitudinal retrospective study that will collect data from three separate cohorts of patients with newly diagnosed multiple myeloma (NDMM). The cohorts classify patients based on whether care is delivered under an intention to adhere to an MRD-targeted clinical pathway, and if so, whether the...
