This trial is evaluating whether Metformin Hydrochloride will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Multiple Myeloma. Measurement will happen over the course of 42 days.
This trial requires 36 total participants across 2 different treatment groups
This trial involves 2 different treatments. Metformin Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Multiple myeloma develops as a result of a problem in the myeloma cells (i.e. the B cells that produce antibody) that normally destroy viruses. It is a disorder that is dependent on environmental factors affecting the development of the myeloma cells.
Patients with MM are likely to relapse. Some patients may experience remissions. The disease does not necessarily progress to lethal bony involvement, and in a few patients, plasma cell dyscrasias may respond to high-intensity chemotherapy. The current data suggest that MM may be a curable disease in a small subset of patients if remission occurs in time to allow for autograft in patients who have responded to conventional treatment.
By 2013, approximately 18.3 million US adults will be diagnosed with at least one type of blood cancer. This makes up 4.7% of the US adult population.
Multiple myeloma can present with a series of symptoms including pain, decreased appetite, or a change in appetite, easy bruising and bleeding, and a high blood protein level. The most common symptom is bone pain and the change in the level of protein in the blood. Tumour mass in myeloma can also cause the bones to become broken or fractured as a result of bone pain and weakness.\n- www.hscbbc.co.
The common treatment options for multiple myeloma patients are [biological therapy] and [immunotherapy]; [chemotherapy/immunotherapy + prednisone/biological therapy] and [bisphosphonates/immunotherapy + prednisone/biological therapy]. We recommend using the most appropriate treatment in each patient. If the [prognosis], [outcomes], or [outpatient support group membership is good], we recommend using the standard-of-care treatment. [Imnunotherapy + dexamethasone is a good choice if there is a bone lesion, hypercalcemia, or symptomatic cardiac arrhythmia.
Data from a recent study, we investigated the use of serum KLH as an immunomarker for diagnosing MM. A positive result in serum KLH testing was indicative of MM and was very specific, with both MM patients and control MZL patients displaying a positive, albeit more weak, reactivity relative to normal serum. Overall, our findings support the view that serum KLH, as a biomarker for MM, may be more specific than immunofixation, a commonly used method for diagnosis of MM. Moreover, serum KLH testing has the potential to outperform both immunofixation and the conventional diagnostic method of MZL.
MM patients are able to take part in an AMH clinical trial. After the introduction of AMH in patients with multiple myeloma from 2015, the survival rate increased significantly and QOL was improved. AMH for multiple myeloma treatment is therefore recommended.
Data from a recent study is the first to elucidate the primary cause of MM in the Korean population. A significant and high proportion of patients with MM were classified as having a nondiagnostic bone marrow lesion. Of those, 12.6% were diagnosed as having an unknown primary malignancy. The most common lesions were non-lymphoid neoplasias, predominantly [myelopoiesis (7.6%) and monoclonal gammopathy of undetermined significance (MUS, 6.6%)] and multiple myeloma (5.8%). Data from a recent study suggest that a careful examination of bone marrow and detection of unknown primary lesions would be important during initial work-up of patients with MM when considering treatment.
The combination of this drug and low-dose thalidomide is more effective than other drugs used to treat multiple myeloma at inducing a partial remission and delaying progression in patients with multiple myeloma for up to 4 years after starting therapy. However, metformin hydrochloride does not have much effect on the duration or nature of multiple myeloma patients with a normal level of kidney function.
Metformin hydrochloride may be indicated for refractory multiple myeloma, based on preliminary evidence from a single observational study but this should be confirmed by an adequately powered RCT before its use can be recommended in clinical practice. Furthermore, other agents may be more effective than metformin and therefore may be preferred for patients with high-risk multiple myeloma. Metformin and other oral hypoglycaemic agents should be used with care during pregnancy and hence should not be routinely used during pregnancy.
The most common side effects of metformin hydrochloride were headache, nausea, and GI bleeding. The rate of nausea and GI bleeding was <5%. Thus it appears safe or feasible to take metformin hydrochloride for longer duration for patients with multiple myeloma or the treatment of type 2 diabetes.
The authors cannot provide a summary of a clinical trial of metformin hydrochloride due to FDA rules and the lack of FDA documentation; however, they confirm that there were clinical trials of metformin hydrochloride use among patients with multiple myeloma.