Active clinical trials for "Multiple Myeloma"

Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.

This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).

In multiple myeloma "cancer stem" cells can be defined and quantified with flow cytometry. More, these cells can be related to treatment response.

The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.

Multiple myeloma is a disorder in which malignant plasma cells accumulate in the bone marrow. These plasma cells produce an abnormal protein called paraprotein / M spike in the serum which can be serially monitored to assess the response of tumour on therapy. The paraprotein has a heavy chain which can be either IgG, IgA, IgM or IgD and a light chain which can be either kappa or lambda. At present, these can be assessed by serum and urine electrophoresis (SPE and UPE). These techniques are relatively insensitive and poorly quantitative compared with other immunoassays for tumour markers. The potential of serum free light chain (flc) measurement as a marker for myeloma has been recognised for some time. However, development of such assays has proved elusive, primarily due to the difficulty in developing assays that are both convenient to use and have the required specificity to measure flc in serum. Recently , the assay has been standardised and is in use. Its likely that the assessment of flc might be a sensitive marker of documenting complete remission in patients with myeloma. The aim of this study is to study the flc in patients with myeloma in complete remission (CR) to see if patients have CR documented by standard criteria- are the free light chains still positive and if so are they better markers of remission. The samples will be collected and tested in batches of 60 each.

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

Based on our previous observations, here the investigator plans to further investigate eNAMPT in MM biology and to establish its role in disease progression where EMT acquisition represents an hallmark of cancers. Results deriving from proposal would hopefully identify novel biological vulnerabilities of such malignancy and an innovative biomarker for disease progression monitoring as well.

Accumulating evidence supports the hypothesis of a pathophysiological role of the Ubiquitin Proteasome System (UPS) in the process of atherosclerosis and vascular function. However the data are contradicting in respect to the direction of this association and therefore the net effect of UPS activity on the cardiovascular system is not known. Inhibitors of UPS are currently standard of care for patients with multiple myeloma (MM). Heart failure and hypertension have been reported in studies of carfilzomib, an irreversible 2nd generation proteasome inhibitor, both as a single agent and in combination with other drugs but their potential vascular toxicity is not adequately studied. Furthermore, as the role of the UPS has not been studied yet clinically but only in experimental and autopsy based studies, assessment of UPS inhibition in humans would facilitate understanding of the UPS-mediated pathophysiologic mechanisms in human atherosclerosis. Thus, this project may stimulate further research on the role of UPS in atherogenesis and potential new therapeutic approaches on vascular dysfunction may arise. We designed the following project in order to investigate the acute and chronic effect of Carfilzomib (CFZ) on cardiovascular function. Patients with an indication to receive CFZ will be recruited to be followed in the Clinical Therapeutics Department in pre-specified timepoints. Functional and structural measurements including markers of arterial stiffness and subclinical atherosclerosis will be performed using non-invasive well-validated techniques. Blood pressure will be also evaluated using 24h hour ambulatory monitoring. Evaluation of cardiac function will be performed at baseline and thereafter at 6 months or earlier if a suspicious event occurs necessitating evaluation of cardiac function. In parallel and at each time point, the activity of UPS and intracellular levels of ubiquitin conjugates will be measured in peripheral blood mononuclear cells (PBMCs) and red blood cells (RBCs) using enzymatic proteasome activity assays and western blot techniques, respectively.

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: 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. 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.