This trial is evaluating whether Venetoclax will improve 4 primary outcomes and 16 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 2 years (Screening, Cycle 3 Day 1, and Confirmation of Stringent Complete Response [sCR]/Complete Response [CR]).
This trial requires 120 total participants across 2 different treatment groups
This trial involves 2 different treatments. Venetoclax 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 2 and have already been tested with other people.
Treatment with R-CHOP-R does not confer increased survival in patients with relapsed or refractory MM. Patients with refractory MM are not candidates for treatment with R-CHOP-R, and the increased toxicity of R-CHOP-R is not justified in these patients. Findings from a recent study suggest that treatment of RR MM with R-CHOP-R yields only delayed progress.
Multiple myeloma may remain dormant for years but may develop into monoclonal gammopathy over time. The presence of a clonal plasma cell proliferation within the bone marrow is the prerequisite for diagnosis of the disease. Some patients with multiple myeloma have no symptoms and may be diagnosed only during routine blood testing. Symptoms of multiple myeloma may not occur until they have progressed to an advanced stage and are symptomatic of a plasma cell type disorder.
Multiple myeloma is a type of cancer that forms in the bone marrow and forms a tumor mass filled with cells that can grow and enlarge in a body's tissues. Multiple myeloma is a disease that can occur in any age group, but it is most often diagnosed in people over the age of 65. Multiple myeloma has high cure rates if properly treated. The five-year survival rates for people with multiple myeloma are 80% to 90%. Multiple myeloma is an incurable disease after conventional treatment with chemotherapy or radiation therapy.
around 60,000 people in the US have newly diagnosed [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in 2017. The prevalence is 2.6/100 000 for men and 1.3/100 000 for women, respectively. There is a good correlation between age and myeloma prevalence. The five most frequently diagnosed and diagnosed sub-classes of disease in the United States are myeloma, lymphoma, breast/ovariary cancer, lung/bronchus cancer and leukemias. The lifetime risk is 1/600 for a healthy person. The cumulative lifetime risk of developing multiple myeloma in a population the size of the United States is approximately 1 in 2 000.
Treatment of myeloma, like treatment of prostate cancer, is highly dependent on the specific case. Common treatments include chemotherapy, radiotherapy and/or transplantation. The combination of these agents is common, particularly with transplantation, and the decision to add a second agents is not always based solely on the disease stage. New therapies targeting the myeloma cell and bone matrix or agents that augment conventional therapy in patients with advanced or metastatic disease, are currently undergoing clinical and laboratory studies. Because the disease remains incurable, treatment should be individualized for as many reasons as are feasible and the patient's needs.
Multiple myeloma is not caused by an excessive production of free light chains. Rather, multiple myeloma occurs because of the accumulation of plasma cells with genetic changes in the DNA which predispose these cells to produce and release proteins that cause B-cell dysfunction. summary: Results from a recent paper found no significant association between multiple myeloma and a number of potential risk factors.
Results from a recent paper suggests that venetoclax is effective in inducing tumor debulking and delaying disease progression in MM patients. Venetoclax is a very effective inhibitor of proliferation and induction of cell apoptosis, both of which are essential for the cytotoxic or cytostatic effect on MM. There were no apparent statistical significance differences with respect to overall or progression-free survival between venetoclax and the placebo arm.
This is the first clinical study of venetoclax in people with newly diagnosed MM. Our safety and tolerability data support evaluating the drug in people with newly diagnosed MM, but not in people with advanced MM. Clin Cancer Res; 1-11. ©2016 AACR.
In a recent study, findings suggest that, among all MM patients receiving treatment with venetoclax, about half did not receive any other treatment. In a recent study, findings suggest that a randomized, placebo-controlled trial of venetoclax-containing combinations in addition to chemotherapy is warranted.
With a new treatment, survival duration is increasing, but this research will help patients choose the treatment that will be best for them. Because the overall five year survival rate from a new treatment to that of the standard treatment was only 37%, the authors urge scientists to continue improving the outcome from existing treatments and to search for new therapies to cure multiple myeloma.
Venetoclax has a well demonstrated role in the treatment of patients with relapsed diffuse large B-cell lymphoma. Clinical trials have shown it to be a very effective drug. It is a drug that is approved by the FDA and EMA for many types of cancer. What has been previously highlighted is the issue of resistance and its potential to develop between patients on venetoclax monotherapy. The current clinical trials will continue to determine the value of this drug in a clinical setting while considering that chemotherapy resistance is a significant issue.
We report a number of common clinical side events associated with venetoclax, including a dose-dependent neutropenia, anaemia, thrombocytopaenia, upper GI disturbances, skin-related symptoms, headache, fatigue and nausea (all with an incidence of ≥10%). Additional side effects were rare in this study, including pulmonary embolism, fever, diarrhoea, dyspnea, hypoxaemia and pneumonitis. Although the incidence of some of these side effects appears lower in the current data compared to that in previous reports and clinical trial databases, clinicians handling venetoclax should be prepared to manage these rare but potentially life-threatening adverse events.