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Myeloma clinical trials

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NCT ID: NCT03776331 Not yet recruiting - Clinical trials for Endothelial Dysfunction

Vascular Functions in Myeloma Patients During Anti-tumor Therapy

Start date: December 28, 2018
Phase:
Study type: Observational

Treatment options for multiple myeloma have increased significantly over the last years with the approval of immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). These therapies have markedly improved overall survival for these patients to a median of 5-7 years. Due to the advanced age, the myeloma patient collective has a high prevalence of pre-existing cardiovascular comorbidities. In addition, the primary disease process contributes to cardiovascular complications. With the beginning of anti-tumor therapy, an increased incidence of cardiovascular complications in myeloma patients can be determined. This includes hypertension, left ventricular dysfunction, heart failure and both arterial and venous thromboembolic events. The detailed mechanism by which proteasome inhibitors and immunomodulatory agents lead to increased cardiovascular events is not established at this time. Endothelial dysfunction, as a possible mechanism of cardiovascular toxicity, is difficult to assess. Flow-mediated dilation (FMD) is an noninvasive method to measure endothelial function by assessing the change in the vasodilatative reserve of the brachial artery. Several independent recent investigations implicate that vascular (endothelial) dysfunction precedes hypertension and heart failure. This has been related to a reduced level of metabolites of the l-arginine-nitric oxide (NO) signaling pathway. Hypothesis: 1. Anti-myeloma therapy exert vascular toxicity by limiting endothelial function. Endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD) decreases after myeloma therapy. 2. Patients with multiple myeloma have a limited endothelial function compared to a healthy control group. A total of 40 myeloma patients will be examined. Measurements will be taken at baseline, 1 month and 6 month after myeloma therapy. Patients should not have received chemotherapy for at least 3 months. Furthermore a healthy sex- and age-matched control group will be examined.

NCT ID: NCT03704597 Active, not recruiting - Myeloma Clinical Trials

Cryotherapy Against Oral Mucositis After High-dose Melphalan

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively.

NCT ID: NCT03702309 Recruiting - Breast Cancer Clinical Trials

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

LIBERATE
Start date: August 3, 2017
Phase:
Study type: Observational

The objective of this protocol is to develop an institution-wide liquid biopsy protocol that will establish a common process for collecting blood and corresponding archived tumor specimens for future research studies at the University Health Network's Princess Margaret Cancer Centre. Circulating cell-free nucleic acids (cfNA), including cell-free DNA (cfDNA) and cell-free RNA (cfRNA), are non-invasive, real-time biomarkers that can provide diagnostic and prognostic information before cancer diagnosis, during cancer treatment, and at disease progression. Cancer research scientists and clinicians at the Princess Margaret are interested in incorporating the collection of peripheral blood samples ("liquid biopsies") into research protocols as a means of non-invasively assessing tumor progression and response to treatment at multiple time points during a patient's course of disease.

NCT ID: NCT03702088 Recruiting - Myeloma Clinical Trials

Place of the Hevylite Test in the Evaluation of MRD in Myeloma

Start date: October 1, 2018
Phase:
Study type: Observational

Study aiming at testing the positive predictive value of the Hevylite blood test in detecting minimal residual disease in myeloma compared to an invasive method requiring bone marrow sample by multi-parametric flow cytometry

NCT ID: NCT03695744 Active, not recruiting - Multiple Myeloma Clinical Trials

Daratumumab in Combination With Bortezomib and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma

Start date: October 2, 2019
Phase: Phase 2
Study type: Interventional

Newly diagnosed Multiple Myeloma patients who are ineligible for a transplant have inferior outcomes to that of the transplant population. This is an area of high unmet need and calls for newer therapies with novel mechanisms of action to improve survival in this non-transplant eligible (NTE) group. Daratumumab is a monoclonal antibody that targets CD38 expressed at high levels on myeloma plasma cells. In phase 1/2 studies, it has demonstrated impressive single agent activity in relapse and refractory myeloma with a very acceptable toxicity profile. This set the stage for combinations with daratumumab to increase efficacy and improve outcomes of patients in both the relapse refractory and newly diagnosed settings. Two large Phase 2 trails using lenalidomide and dexamethasone or bortezomib and dexamethasone along with Daratumumab demonstarted the impressive efficacy of antibody based 3 drug combinations in the relapsed refractory myeloma setting. More recently a large clinical trial using a Bortezomib based 4 drug combination with Daratumumab was reported from Europe in the first-line treatment of transplant ineligible Myeloma patients showing very good survival outcomes. Hence the investigators hypothesize that the combination of Daratumumab with bortezomib and dexamethasone in the NTE population may therefore improve efficacy and clinical outcomes.

NCT ID: NCT03641456 Recruiting - Myeloma Clinical Trials

VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

Start date: September 25, 2020
Phase: Phase 2
Study type: Interventional

The phase 2 study evaluated the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy in high risk newly diagnosed multiple myeloma patients who receive lenalidomide,bortezomib, and dexamethasone Combination as induction therapy.

NCT ID: NCT03633955 Recruiting - Clinical trials for Acute Myeloid Leukemia

Pilot Imaging Study of Leukemia

REALIZE
Start date: January 19, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.

NCT ID: NCT03618212 Terminated - Myeloma Clinical Trials

MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

MYMO
Start date: December 21, 2018
Phase:
Study type: Observational

The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.

NCT ID: NCT03591614 Withdrawn - Myeloma Clinical Trials

Dendritic Cell DKK1 Vaccine for Monoclonal Gammopathy and Stable or Smoldering Myeloma

Start date: December 1, 2023
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to study the safety and preliminary efficacy of a dendritic cell DKK1 vaccine against myeloma. Dendritic cells are immune cells that are collected from the blood of the patient at Case Western Reserve Medical Center and then brought into contact with DKK1, a molecule that is present of myeloma cells but not to a significant amount on other cells except for the prostate and the placenta. It is an investigational (experimental) vaccine that based on studies in the laboratory and in mice is expected to work by presentation of DKK1 to anticancer immune cells via dendritic cells leading to an immune attack on myeloma cells. It is experimental because it is not approved by the Food and Drug Administration (FDA).

NCT ID: NCT03574454 Active, not recruiting - Myeloma Clinical Trials

Machine Learning in Myeloma Response

MALIMAR
Start date: July 4, 2018
Phase: N/A
Study type: Interventional

Diffusion-weighted Whole Body Magnetic Resonance Imaging (WB-MRI) is a new technique that builds on existing Magnetic Resonance Imaging (MRI) technology. It uses the movement of water molecules in human tissue to define with great accuracy cancerous cells from normal cells. Using this technique the investigators can much more accurately define the spread and rate of cancer growth. This information is vital in the selection of patients' treatment pathways. WB-MRI images are obtained for the entire body in a single scan. Unlike other imaging techniques such as computed Tomography (CT) or Positron Emission Tomography (PET) PET/CT there is no radiation exposure. Despite the considerable advantages that this new technique brings, including "at a glance" assessment of the extent of disease status, WB-MRI requires a significant increase in the time required to interpret one scan. This is because one whole body scan typically comprises several thousand images. Machine learning (ML) is a computer technique in which computers can be 'trained' to rapidly pin-point sites of disease and thus aid the radiologist's expert interpretation. If, as the investigators believe, this technique will help the radiologist to interpret scans of patients with myeloma more accurately and quickly, it could be more widely adopted by the NHS and benefit patient care. The investigators will conduct a three-phase research plan in which ML software will be developed and tested with the aim of achieving more rapid and accurate interpretation of WB-MRI scans in myeloma patients.