Selinexor for Multiple Myeloma
Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma
See full descriptionAbout the trial for Multiple Myeloma
Treatment Groups
This trial involves 2 different treatments. Selinexor 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.
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 one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Selinexor will improve 3 primary outcomes and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 6 months.
Patient Q & A Section
What causes multiple myeloma?
Multiple myeloma can result when antibody-producing plasma cells, the type of lymphocyte that normally produce the antibodies, are overproduced but fail to leave the bone marrow. Multiple myelomagenesis is not only an immunological phenomenon. Other nonimmunological causes have been suggested over recently. The pathogenetic mechanism of multiple myeloma may include a clone of myeloma cells that escapes deletion by the regulatory mechanisms of the bone marrow.
Can multiple myeloma be cured?
With good control of disease, some patients may be free of disease over 5 years, while others are still suffering relapsed disease. Current disease-modifying concepts in MM do not allow for a cure.
What are the signs of multiple myeloma?
The main symptoms include, bone pain, decreased appetite, low body weight, nausea and poor energy level. If an individual exhibits these symptoms for more than 3 months, it recommends that patient be referred to the medical team.\n\nThe clinical manifestations of disease are as follows:\n\n- Hematopoetic disease is mainly caused by the presence of malignant cells that invade any part of the blood.
What is multiple myeloma?
Around 80% of cases of MMC show one or more of the following symptoms: tiredness, weight loss, anemia, skeletal pain, fever, night sweats, and/or itchiness. Bone marrow biopsy is necessary to definitively diagnose this disorder.\n
How many people get multiple myeloma a year in the United States?
The number of new diagnoses of multiple myeloma a year in the United States is expected to increase at a rate of 8% over 4 years. It is important to understand this new trend and implement the needs of the newly diagnosed patient population.
What are common treatments for multiple myeloma?
Overall survival is low for patients with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma). Most multiple myeloma is treated with systemic administration of high-dose bortezomib with or without dexamethasone. Novel agents were being studied in clinical trials for high-risk myeloma in the second and third decade of the 21st century. Patients treated with a combination of high-dose therapy and autologous stem cell transplantation have significant improvements in survival. There is ongoing trial for high-dose bortezomib-based regimes in patients with multiple myeloma.
What are the chances of developing multiple myeloma?
Overall, this study concluded that even though the risk of developing multiple myeloma is higher for the frail elderly, it is extremely difficult to determine accurately the individual risk of developing multiple myeloma based only on general health status. Although the elderly are at the highest risk of multiple myeloma, they need to be evaluated individually to make a more effective treatment plan tailored to their specific risks and needs.
How does selinexor work?
[For more information on selinexor, see (S-7010), a new drug in clinical trials that prevents the proliferation of cancer cells with the same translocation as found in multiple myeloma.] One study suggests that selinexor is more effective than the current standard, Velcade (Bortezomib). Velcade binds to the catalytic domain of a ubiquitin ligase (c-E3) which marks proteins that are to be degraded. It is this mark that in the future may lead to selinexor's toxicity. Multiple myeloma is a disease in which the proteasome is abnormally active.
What are the common side effects of selinexor?
Among the most commonly reported side effects in patients treated with selinexor are thrombocytopenia, diarrhea, nausea and vomiting, gastrointestinal hemorrhage, rash, headache, hyperlipidemia and hepatitis. Findings from a recent study also found that the magnitude of these events increases over time according to the number of cycles of treatment. The incidence of most side effects is lower for patients in a subset of these trials with more myalgias. Selinexor was efficacious in the first-line setting in our study and seems to be generally well tolerated in this patient population with relapsed and/or refractory disease.
What does selinexor usually treat?
Current and past clinical trials as well as the prescribing information describe selinexor as a treatment for multiple myeloma. Further studies are needed to evaluate selinexor in multiple myeloma to determine whether the benefit detected at FDA approval persists when patients are taken off treatment, as happens with other agents of this class.
How serious can multiple myeloma be?
The seriousness of MM may vary greatly at presentation, especially in myeloma patients<40 years old. The most important factor in the management of MM is careful treatment compliance.
What is selinexor?
Selirexor was effective as a single agent and combined with bortezomib in relapsed/refractory multiple myeloma. Selirexor can be an effective treatment option for patients with multiple myeloma.