This trial is evaluating whether NMS-03597812 will improve 1 primary outcome and 19 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of From the Informed Consent signature to 28 days after the last dose of study treatment administration.
This trial requires 65 total participants across 3 different treatment groups
This trial involves 3 different treatments. NMS-03597812 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
"(1) Nms-03597812 is an active agent in relapsed or refractory MM; it achieves high response rates and durable responses, with a manageable toxicity profile when used in combination with chemotherapy regimens containing bortezomib. (2) The activity of Nms-03597812 is not significantly impacted by combination with dexamethasone. (3) The antitumor activity of Nms-03597812 appears to be associated with Bcl-xL downregulation." - Anonymous Online Contributor
"Multiple myeloma is caused by mutations in B cells (B lymphocytes) that produce the antibody RAG1, which detects foreign material in the body. There are more than 40 known mutations on this gene. The mutations in RAG1 cause reduced function of the enzyme immunoglobulin light chain enhancer and combine with other genetic alterations to create multiple myeloma. The rate of acquiring multiple myeloma increases when there are fewer CD4 T helper cells in the immune system. There is no link between smoking or asbestos exposure and developing multiple myeloma.\n\nThe incidence of multiple myeloma varies widely among countries. Rates have decreased since the 1970s due to improved mortality from other cancers." - Anonymous Online Contributor
"There are many new developments in treating MM at every stage of the disease, including research on novel drugs, new combinations of existing drugs, new immunotherapies, and novel approaches to reduce the effects of MM on the patient with severe symptoms. These advancements vastly improve the quality of life of MM patients while allowing them to continue living full lives." - Anonymous Online Contributor
"The majority of patients with MM were able to complete initial therapy; however, approximately one third experienced relapse within 12 months. Results from a recent clinical trial represents the largest series of long-term follow-up data for MM treated with standard regimens." - Anonymous Online Contributor
"Findings from a recent study has shown that NMS-03597812 demonstrates significant improvement in clinical efficacy over previous Bortezomib formulations, including improved safety profile and tolerability profiles. It also demonstrated superiority against previously established bortezomib therapies in terms of clinical benefit and QOL. Findings from a recent study supported further development of NMS-03597812 as a new therapeutic option for MM." - Anonymous Online Contributor
"The overall 5-year survival rate for patients diagnosed with MM at this institution was 82%. Patients who underwent autologous stem cell transplantation had a higher 5-year survival rate than patients who did not (95% vs 79%, P = 0.007). Patients with EMZL were also shown to have a significantly better outcome after diagnosis compared with those with ALK+ MM (93% vs 74%, P = 0.013). This supports the notion that certain subgroups of patients might benefit from a more aggressive approach, including ASCT, in order to improve outcomes." - Anonymous Online Contributor
"The treatments used to treat patients with multiple myeloma vary widely based on the characteristics of each patient's disease and may include combinations of agents (combination therapy). Treatment is mainly aimed at reducing pain, improving performance status, increasing quality of life, and delaying progression from multiple myeloma into acute myeloid leukemia. Although many patients have been treated successfully, there has been no evidence that any particular treatment leads to an improvement in survival over others. [With Power(www.withpower." - Anonymous Online Contributor
"The chance of developing MM increases with age. Men in their 60s and 70s have about twice the risk of developing MM compared to younger men. Women who develop MM tend to be younger (40-49 years old) and have larger amounts of bone marrow plasma cells. Multiple myeloma is a rare disease with approximately 4,500 new cases in the U.S. each year. The average survival time from diagnosis is approximately 10 years." - Anonymous Online Contributor
"The data suggest that multiple myeloma may have an autoimmune basis. The data are consistent with the hypothesis that a defect in B-cell tolerance predominates in the development of this disease." - Anonymous Online Contributor
"Nms-03597812 was well tolerated In a recent study of people with MM. The improvement in QOL observed here was consistent with results from other small studies of NMS-03597812 in patients with MM." - Anonymous Online Contributor
"Nms-03597812 has been studied in an open-label trial (NCT02472168) in patients with relapsed multiple myeloma. It was well tolerated and showed efficacy In a recent study. The drug did not show activity in phase II studies but has shown promising results in phase III trials." - Anonymous Online Contributor