Cilta-cel for Multiple Myeloma
This study is evaluating whether a new treatment for multiple myeloma is better than the standard treatment.
See full descriptionAbout the trial for Multiple Myeloma
Treatment Groups
This trial involves 2 different treatments. Cilta-cel is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Cilta-cel will improve 1 primary outcome and 21 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to Day 112.
Patient Q & A Section
What is multiple myeloma?
Multiple myeloma is a rare disease with an estimated incidence rate of 1.5 cases per 100,000 person-years in the USA. Its average survival time is 5 years. While several treatments exist for multiple myeloma, only two drugs (bortezomib and lenalidomide) are FDA approved for the disease, meaning they are widely used. However, there is no consensus on how to treat multiple myeloma patients. Because of this, there are many ongoing clinical trials being conducted at universities and hospitals across the country. Overall, the most effective treatments are still under study and research. To find active clinical trials in your area, you can go to [Power(http://wwwncdi.
What causes multiple myeloma?
Multiple myeloma is caused by the abnormal production of immunoglobulin G (IgG), and IgG is produced by B lymphocytes. The discovery of the B cell helps us understand how we develop our own immune system. In addition to autoimmune diseases, there are many other autoimmune diseases which have similar features to multiple myeloma including celiac disease, lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Behçet's disease, type 1 diabetes, multiple sclerosis, and sarcoidosis.
Does multiple myeloma run in families?
Results from a recent clinical trial shows that myeloma runs in families, but the penetrance of myeloma appears to be very low. The finding that there were more affected siblings than expected by chance suggests an autosomal dominant inheritance pattern. The genetic basis of familial myeloma will likely remain unknown until further family members with myeloma are studied.
What is the primary cause of multiple myeloma?
The majority of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) cases have an unknown cause. The risk factors for multiple myeloma include exposure to environmental pollutants and radiation. The International Myeloma Working Group found that ionizing radiation was associated with increased risk of multiple myeloma and showed that this association depended on the type of radiation. A causal relationship between ionizing radiation and multiple myeloma has not been established. Other studies suggest that there might be an association between dietary vitamins D and E and the development of multiple myeloma; however, no clear evidence supports this claim. The incidence rate of multiple myeloma increases with age; thus, the probability of developing multiple myeloma increases with age.
What is the average age someone gets multiple myeloma?
The median age for MM was 67, which was similar to the age of 58 for all cancer cases during 2008-2011. However, the estimates were based on cases detected through surveillance rather than through an active case-finding process.
What are the latest developments in cilta-cel for therapeutic use?
Cilta-cel inhibits two forms of CD19 on B cells, IgM and IgG. It also targets the T cell receptor (TCR), inhibiting their activation and proliferation. In addition, it preferentially targets abnormal pre-B lymphocytes. Clinical studies have reported that patients receiving Cilta-cel had significant improvement in symptoms, such as fatigue, nausea, night sweats, loss of appetite, and general discomfort. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2013.
Have there been any new discoveries for treating multiple myeloma?
There have only been a few newly discovered agents that showed promising results in MM. The current standard of care is to use high doses of alkylating agents plus steroids. In the past few years, there has been interest in developing other novel techniques such as bortezomib and lenalidomide. These agents targeting proteasome inhibitors or immunosuppressive agents, respectively, are being investigated. A recently completed trial suggests that there may be benefit to giving autologous stem cell transplantation before the start of the first line therapy. However, these treatments are still experimental and more data are needed to determine their role in treating MM.
Does cilta-cel improve quality of life for those with multiple myeloma?
[Cilta-cel] increased anxiety and depression scores, decreased HRQoL, and reduced overall survival in MM patients (P=0.003). Interestingly, improved HRQoL was maintained at 24 months post-treatment. Findings from a recent study will need to be confirmed in randomized controlled trials.
Can multiple myeloma be cured?
A small proportion of patients with multiple myeloma will experience a complete remission regardless of therapy. Recent findings demonstrate that patients are likely to succumb to the disease before achieving such an outcome.
What are common treatments for multiple myeloma?
MM is an incurable disease, and patients usually survive 5 years after diagnosis. Treatment for MM is typically based on its staging (see definition below) and the risk category a patient falls into. Cyclophosphamide is used as initial therapy; with or without steroids, depending on the risk category. The goal of chemotherapy is to induce remission in as many patients as possible. In those treated with steroid alone, they should receive high dose intravenous cyclophosphamide weekly for 2 to 3 months. Follow up evaluations are then needed every 6 months, and later every 12 months.
Have there been other clinical trials involving cilta-cel?
Cilta-cel has yet to show any benefit in multiple myeloma. There have been different combinations used for phase III trials. There is no evidence to support the superiority of one formulation over another. Ixazomib failed to get FDA approval and was voluntarily withdrawn from further development. Nevertheless, cilta-cel remains an option for patients with multiple myeloma.