Selinexor for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of selinexor as a treatment for people with multiple myeloma, a type of blood cancer, who haven't responded well to other therapies and have undergone CAR-T cell therapy. Researchers aim to determine if selinexor can safely prevent cancer growth after CAR-T treatment. It may suit individuals who have received CAR-T therapy but still show signs of cancer and have difficult-to-treat multiple myeloma. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take any other treatments for multiple myeloma during the study. You may continue corticosteroids if they are for conditions other than multiple myeloma.
Is there any evidence suggesting that selinexor is likely to be safe for humans?
Research has shown that selinexor, tested in patients with multiple myeloma, is effective but can cause side effects. The most common side effects include nausea, vomiting, diarrhea, tiredness, and loss of appetite. While these side effects are often manageable, some patients have discontinued treatment because of them.
A review of selinexor treatments in multiple myeloma found that the drug generally works well, with side effects that most people can handle. However, some patients did stop using it due to these side effects. This indicates that while selinexor can be effective, careful monitoring is necessary to manage any side effects.12345Why do researchers think this study treatment might be promising?
Selinexor is unique because it targets a protein called XPO1, which plays a crucial role in cancer cell survival. Unlike many standard treatments for multiple myeloma, such as proteasome inhibitors and immunomodulatory drugs, selinexor works by inhibiting this protein, leading to the accumulation of tumor-suppressing proteins in the nucleus and ultimately causing cancer cell death. Researchers are excited about selinexor because it offers a novel mechanism of action that might be effective for patients who have a high risk of relapse, potentially providing a new option where existing treatments may not be sufficient.
What evidence suggests that selinexor might be an effective treatment for multiple myeloma?
Previous studies have shown that selinexor holds promise in treating multiple myeloma, particularly when combined with other treatments. Research indicates that selinexor can help prevent cancer progression for an average of 4.7 months. In this trial, participants will receive selinexor, which is most effective when used with corticosteroids and proteasome inhibitors (PIs). Selinexor directly targets cancer cells and does not interfere with T-cell collection for CAR-T therapy, making it a safe option for patients undergoing this advanced cancer treatment.26789
Who Is on the Research Team?
Mark A Schroeder, M.D.
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for patients with multiple myeloma who have not responded well to triple-therapy and have undergone CAR-T therapy. It's specifically aimed at those with high-risk features like adverse risk cytogenetics, less than complete response post CAR-T, or extramedullary disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive selinexor starting on Day 30 after CAR-T infusion for up to 12 cycles, with weekly doses on Days 1, 8, 15, and 22 of each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of complete response and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Selinexor
Trial Overview
The study tests Selinexor as a maintenance treatment after CAR-T cell therapy in multiple myeloma patients. The goal is to see if it can improve minimal residual disease rates and extend the time without disease progression.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with high risk of relapse will receive selinexor starting between Day 30 - Day 58 after cilta-cel infusion for up to 12 cycles (initiation of treatment may be delayed from day 30 for up to 28 days to allow for MRD testing to results or for a patient experiencing ongoing cytopenias). Selinexor will be given weekly on Days 1, 8, 15, and 22 of each 28-day cycle. The first 3 to 6 patients enrolled will be part of the safety run-in cohort; these patients will be monitored for dose-limiting toxicities during Cycle 1. Provided the safety run-in shows that selinexor is safe and tolerable at this dose, an additional 14 to 17 patients (for a total of 20) will be enrolled.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Karyopharm Therapeutics Inc
Industry Sponsor
Richard Paulson
Karyopharm Therapeutics Inc
Chief Executive Officer since 2021
MBA from the University of Toronto's Rotman School of Management
Reshma Rangwala
Karyopharm Therapeutics Inc
Chief Medical Officer since 2023
MD, PhD
Citations
Real-World Treatment Patterns and Survival Outcomes of ...
Patients had a real-world overall survival (rwOS) of 14.7 months (95% CI: 10.6, 20.9) and a derived progression-free survival (dPFS) of 4.7 ...
Efficacy and safety of selinexor for patients with relapsed ...
Selinexor is more effective when used in combination with corticosteroids and PIs compared to when used alone. It is effective in both relapsed and refractory ...
3.
targetedonc.com
targetedonc.com/view/notable-outcomes-of-selinexor-based-triplet-therapy-addressed-in-rrmmNotable Outcomes of Selinexor-Based Triplet Therapy ...
After a median follow-up of 13.2 months (IQR, 6.2-19.8) in the triplet arm and 16.5 months (IQR, 9.4-19.8) in the doublet arm, the median PFS ...
Lower dose and weekly schedules of selinexor in multiple ...
Results: Updated results on once-weekly selinexor in combination with other anti-MM agents showed a reduced adverse event profile and improved ...
5.
ashpublications.org
ashpublications.org/blood/article/140/Supplement%201/7152/489718/Real-World-Efficacy-and-Toxicity-of-SelinexorReal World Efficacy and Toxicity of Selinexor - ASH Publications
Starting dose was 40-100 mg per week in 16 (37%) and >100 mg week in 28 (63%) pts. Median duration of selinexor therapy was 2.7 months. On ITT, ...
Safety assessment of selinexor: a real-world ...
Clinical trials of selinexor in patients with multiple myeloma were reviewed. We investigated selinexor-related adverse events through data ...
Safety and Efficacy Analysis of Selinexor-Based Treatment ...
Our meta-analysis revealed that selinexor-based regimens could offer reasonable efficacy and tolerable adverse events in patients with multiple myeloma.
8.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/7080/527411/Response-and-Safety-of-Selinexor-with-VRD-RegimenResponse and Safety of Selinexor with VRD Regimen in ...
The combination of selinexor with VRd regimen demonstrated early, deep, and durable responses in NDMM patients with extramedullary disease, both ...
Integrated safety profile of selinexor in multiple myeloma
The most common adverse events (AEs) are gastrointestinal (nausea, vomiting, and diarrhea), constitutional (fatigue, decreased appetite), ...
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