This trial is evaluating whether Rapid Infusion Isatuximab will improve 1 primary outcome and 1 secondary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 9-12 weeks depending on isatuximab dosing interval.
This trial requires 10 total participants across 2 different treatment groups
This trial involves 2 different treatments. Rapid Infusion Isatuximab 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.
Most multiple myeloma are idiopathic and do not seem to have a specific cause or cause. It is more common in older patients and in those with autoimmune diseases. More studies of multiple myeloma are needed to better understand and treat the disease.
The following is an explanation of the myeloma concept. Please note:\n\nBacille Calmette, the microbiologist who first identified the "Mycoplasma pneumoniae" organism in 1849, gave it the name pneumococci, which would have made it the first bacterium described by modern science (1848), and a member of the phylum "Bacteriens", where members can grow in chains or as single cells. The word "bacterium" would have a "bad" connotation of small, rodlike, and not very infectious.
In patients suffering from relapsing/refractory multiple myeloma, conventional cytotoxic drugs are not the first or preferred treatment, since they only offer a modest improvement over treatment with oral agents that induce remissions. On the contrary, patients with very fast-developing, progressive, more-aggressive forms of multiple myeloma are usually given a combination of bortezomib with carfilzomib or bevacizumab and autotransplantation of the bone marrow.
It is difficult to estimate the number of cases of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) in the general population from a single national prevalence study. The national and regional prevalence estimates differ greatly, and estimates for single years must be interpreted with caution. It is difficult to determine whether trends in incidence are continuing for multiple myeloma or whether increases in incidence reflect increases in diagnosis, not in patient numbers. If incidence is rising, it is unlikely that many cases are newly diagnosed at a time when patients with myeloma have low survival rates, which may distort the estimates of incidence. If the incidence is not rising, detection of cases is likely to have risen in proportion to the actual number of new cases.
Survival in MM varies depending on the stage at presentation, but it is very likely that improvements in treatment are necessary to allow control of the disease.
Given a favorable side effect profile, the data demonstrate for the first time that isatuximab in this way produces significant and lasting benefit on QoL among patients with multiple myeloma, and further supports the early application of the drug in this difficult-to-treat population.
The clinical data for new drug treatments of multiple myeloma are currently accumulating. Continued trials are needed to confirm the role of new drug therapies in MM treatment.
Both myeloma (45% of cases) and Waldenström disease (10% of cases) are associated with primary malignancy. Although the etiology of BMF is unknown, its association to multiple myeloma implicate B-cell proliferation and/or cytokines as the pathogenic processes for BMF and multiple myeloma, respectively.
ISA is well tolerated by patients receiving treatment for relapsed or refractory myeloma. The most common side effects are infusion reactions, febrile neutropenia, and infection, and neutropenia was the most troublesome. Because of the potential toxicity of an immune deficiency state, a slow infusion rate (for 10–12 hours or less) was recommended when starting ISA.
The number of treatment options for patients with multiple myeloma has increased significantly during the last decade, and new treatment options are being launched at an increasing pace. The number of patients with refractory multiple myeloma has remained relatively static, so some of the new treatments may have less-than-expected utility in the clinical setting.
Results from a recent clinical trial suggests that multiple myeloma is genetically and biologically heterogeneous. Some cancers may be the result of simple genomic changes (single nucleotide polymorphisms, SNPs), whereas others may reflect complex genetic interactions among numerous loci.