This trial is evaluating whether Metformin XR will improve 1 primary outcome and 9 secondary outcomes in patients with Monoclonal Gammopathy of Undetermined Significance. Measurement will happen over the course of Baseline to 6-months.
This trial requires 80 total participants across 2 different treatment groups
This trial involves 2 different treatments. Metformin XR is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
"Patients with MGUS have no specific clinical signs or symptoms (though it is uncommon to remain asymptomatic for an extended period of time due to multiple small subclinical organ failures of the adaptive immune system); thus, the presence of monoclonal IgM in blood should be regarded as a clue to the underlying disease. MGUS patients exhibit a high rate of evolving to MGUS and, if left untreated, then to myeloma. The MGUS diagnosis should be made at the time of blood testing, even if the result does not indicate the presence of monoclonal IgM; the latter is only indicated within 6 months of initiating a therapy that inhibits the production of the IgM paraprotein (e.g." - Anonymous Online Contributor
"The incidence of MMUS is increasing. Men are more often affected by MMUS, probably reflecting a higher prevalence of prostate cancer in men than in women. The presence of MMUS does not indicate increased cardiovascular risk and does not preclude curative treatment." - Anonymous Online Contributor
"Results from a recent clinical trial in our small cohort (N = 4) suggest that MOGUS cannot be eradicated, because of its persistence despite treatment. However, they are encouraging since MOGUS may be a benign monoclonal clonal phenomenon, and long-lasting remission even after initiation of active therapy has to be verified in a larger cohort." - Anonymous Online Contributor
"Monoclonal gammopathy of undetermined significance (MGUS) is characterized by a variable accumulation of a monoclonal immunoglobulin in blood. We hypothesize that the increased activity of monocyte/macrophage-derived interleukin 6 (IL-6) is a key step in its development." - Anonymous Online Contributor
"MGUS is a monoclonal plasma cell disorder characterized by a proliferative plasma cell response to a previously unexposed antigen. It accounts for 85-90% of plasma cell dyscrasias after polyclonal response to an antigen. MGUS is most often detected as a incidental finding because its signs, symptoms, and complications are similar to those of a normal condition." - Anonymous Online Contributor
"Patients with M-UMG and/or M/M may benefit from immunosuppressive medication (including calcineurin inhibitors and steroidal immunosuppressants), but patients with more frequent and intense B cell stimulation may benefit from immunostimulatory therapy (e.g., rituximab)." - Anonymous Online Contributor
"The first monoclonal gammopathy of undetermined significance-related blood test resulted in an antibody test to evaluate for the presence of a monoclonal gammopathy, however, it did not help diagnose a specific disorder. For the diagnosis of multiple myeloma, it was necessary for a patient to demonstrate clonal gammopathy, low concentration of monoclonal IgM protein in their urine/serum, and bone marrow plasma cell dysplasia in order to be diagnosed with multiple myeloma. The only screening test has been found to have high sensitivity and specificity, which means it will not miss or make a diagnosis when a person doesn't have cancer." - Anonymous Online Contributor
"Metformin-XR does not help, but significantly increase plasma glucose levels as compared with metformin; therefore, it should be avoided in patients who have any diabetic disturbances." - Anonymous Online Contributor
"The majority of respondents believed that clinical trials for MGUS should include patients who should be candidates for curative therapy, although opinions varied on the optimal frequency at which such therapy should be offered." - Anonymous Online Contributor
"The presence of MGUS/MZH did not significantly impact family cancer risk. However, these results might not be as strong as they looked when this was evaluated in a cohort study." - Anonymous Online Contributor
"Patients treated with metformin xr were younger and healthier than those receiving placebo. Only one serious adverse event was reported (hemorrhage) in association with both treatments. There were no patients reported with lactic acidosis and no reported cardiovascular conditions. Because of its safety and the need for a new treatment for MUG, we recommend metformin xr for the treatment of MUG, the first new agent for this disease reported in more than 20 years." - Anonymous Online Contributor
"Patients with MGUS have an early average survival rate of approximately 4.0 years, and those with overt MM have an additional risk factor of mortality. If MGUS is diagnosed at or before the onset of MM, the average survival rate is much higher. Thus, MGUS should be considered a precancerous condition, and not a mere diagnosis of 'Monoclonal gammopathy of undetermined significance." - Anonymous Online Contributor