This trial is evaluating whether Ixazomib will improve 1 primary outcome and 5 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Time from protocol therapy initiation to the disease progression or death from any cause, censored at date last known progression free for those who have not progressed or died, or up to 60 months post initiation of therapy.
This trial requires 55 total participants across 2 different treatment groups
This trial involves 2 different treatments. Ixazomib 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.
MM incidence has risen significantly in the past 15 years in the U.S., [even in individuals with normal serum protein levels] which was also documented in European reports , . MM incidence also varies geographically, in a manner similar to that of age and sex, [2,3]. The increased incidence of MM, especially in elderly individuals, is likely not to occur because this is not a disease of middle age. It is postulated that MM is attributable to an environmental trigger that has been identified and that it may be a disease of people who have a genetically predisposed immunodeficiency of the immune system.
M-symptoms and abnormalities of the blood and urine in cancer patients should prompt further testing of interest. Nail lesions, thrombocytosis, protein in the urine, low serum albumin and low platelet count would
There is limited evidence that cigarette smoking or exposure to occupational irritants is associated with a modest increased risk of developing multiple myeloma after controlling for environmental exposures, including diet and genetic factors. Future studies are needed to further elucidate the mechanisms by which multiple myeloma develops.
The most common type of plasma cell dyscrasia is multiple myeloma but it is a heterogeneous disease with several subtypes. It is a neoplasm of plasma cells but that's not always the case; in addition to multiple myeloma, many other disorders have their origins in plasma cells. Multiple myeloma is characterized by the proliferation of plasma cells that have one of several genetic abnormalities, generally t(14;18).
Multiple myeloma has historically been treated with high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. However, the combination of autologous bone marrow transplantation and high-dose chemotherapy has been shown to result in a prolonged survival time. Therefore, autotransplantation has become the standard method of chemotherapy for multiple myeloma. Although patients with newly diagnosed early-stage multiple myeloma may be eligible for autografting and maintenance chemotherapy, there are no well-defined guidelines for multiple myeloma patients who are candidates for autotransplants. Clinicians must balance the benefits and risks of salvage procedures against a patient's physical abilities to complete the procedure.
The 5 year and 10 year overall survival were 74% and 62% for patients with MM, respectively. There were no significant differences found with respect to age, gender, type or number of M-MM subclones, RISS, and Bortezomib dosage, and treatment duration.
Ixazomib did not induce the common side effects of lenalidomide. For some side effects, lenalidomide produced higher incidence of side effects than ixazomib. The rate of nausea and vomiting in ixazomib treatment were similar to that in lenalidomide treatment. Ixazomib did not alter or delay the resolution of diarrhea and constipation experienced with lenalidomide treatment. The most common grade>or=2 side effects of ixazomib therapy were fatigue, depression, vomiting, diarrhea, asthenia, headache, and dizziness.
Ixazomib is very effective with a manageable and tolerable side effect profile, and it is well-tolerated in both patients with newly diagnosed multiple myeloma and those in remission.
Ixazomib seems to work in MM that has relapsed after more than one lines of therapy. More investigations, such as a long term effectiveness study, are needed to better understand which treatments work for what patients.
Most (59%) of the respondents in this survey first developed multiple myeloma before the age of 40 years. People most often develop multiple myeloma in the fifth decade of life (31% of the respondents), while almost half first developed multiple myeloma after the age of 70 years.
There was one ongoing clinical trial for myeloma at the time of writing. The drug failed three times in its last two cycles. As of August 2019, the Drug Information Center at the National Cancer Institute lists a number of ongoing clinical trials involving ixzomib on its webpage. The American Society of Hematology recommends ixzomib for patients with newly diagnosed, relapsed or refractory multiple myeloma.
On average, survival time (also referred to as progression-free survival or FPS) for patients with multiple myeloma after treatment with an [Interferon alpha (IFNα) or Bortezomib (BZ)(Velcade)(Zorznain, Vypros, Zelboraf, Tecerdapim)] is approximately 5-8 months. Median progression free time after [IFNα] is approximately 4 months, whereas [BZ] is approximately 12 months. One-year survival has not changed significantly since [BZ] treatment.