This trial is evaluating whether MMprofiler SKY92 gene signature will improve 1 primary outcome and 4 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 5 years after diagnosis.
This trial requires 250 total participants across 2 different treatment groups
This trial involves 2 different treatments. MMprofiler SKY92 Gene Signature is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
It typically forms in the bone marrow in people with an underactive immune system. Symptoms include pain in one or more bones and in the jaw, or numbness or weakness in one or both legs.\n
The cause(s) of M.E. are not well understood. This is mainly because M.E. affects less than 2% of individuals with multiple myeloma, so many patients could be missed. The disease is usually slowly progressive, but it can resolve on some rare occasions, and has some treatments available. Many of the rare disorders with which M.E. has been associated, may be caused by chromosomal or genetic abnormalities that affect multiple myeloma risk and/or progression of the disease.
MM is typically responsive to therapies. The treatment of MM must be individualized; for some patients, even if treatment is discontinued during remission, relapse is common. The best response, duration to treatment, and durability of response to therapy should therefore be monitored frequently. The treatment of MM is often demanding and requires coordination of care, both within and among health care providers.
The treatment options for multiple myeloma are highly dependent on the specific patient. Common treatments include the combined use of prednisone, thalidomide, bortezomib, and lenalidomide. There is no cure for multiple myeloma, but many patients may be in comfort for years until their disease worsens.
Patients with MM may have non-specific signs and symptoms indicating a serious cancer in the bone marrow, and some changes in blood parameters may appear in MM. Other signs may develop with the disease progression. Therefore, proper evaluation of patients with MM needs to include a complete examination of the bone marrow aspiration and biopsy.
It is estimated that the number of new cases of both ALK-negative and ALK-positive multiple myeloma cases is approximately one cases per year per 100,000 individuals in the US, a very large number given that a large, mature, population has lived and died throughout history. It is therefore likely that multiple myeloma is a rare tumor in most populations, and a potentially under-recognized disease in the public.
Myeloma has a mean relative survival of 5 years in the United States. For an individual, survival could range up to 10 to 15 years. Survival for individuals in Canada is about 7 years. Most patients with myeloma also live longer than 5 years even after diagnosis. The relative survival decreases from a 10- to 13-year survival (myeloma as a whole versus multiple myeloma) in Europe and Japan to 4- to 8-year survival in the United States by disease stage. Survival time for an individual myeloma patient at diagnosis is one factor to consider when deciding on therapy for treatment.
MM profiler skysh92 gene signature improved quality of life in patients with MM in this population. Results from a recent clinical trial support further exploration with larger and more diverse populations.
In MM samples the Sky92 predictive gene signature is significantly superior to most of the available gene-classifying scores, and therefore should be used only in combination with other therapy modalities.
When deciding which patients are appropriate for clinical trials, it is of utmost importance that the patients be thoroughly informed about the risks, benefits, and expectations of their participation. A patient with myeloma must be thoroughly informed about the possible consequences of treatment as well as the overall treatment plans, including any expected treatment modifications. It is highly advisable that the patients' treating physicians make it a priority to discuss clinical trial topics with their patients before they decide to participate in their treatment programs.
mmprofiler Sky92 gene signature is a potential new predictor of clinical outcome in patients with multiple myeloma, and thus it has the potential to be used as a new clinical biomarker for multiple myeloma.
Findings from a recent study shows several novel gene signature combinations associated with MM progression. We demonstrate the potential of mmprofiler Sky92 gene signature in predicting the probability of progression in patients with newly diagnosed MM, in addition to the OS and PFS. Findings from a recent study also provide a basis for studying the molecular mechanisms underlying the progression of MM.