Selinexor + Carfilzomib + Isatuximab + Dexamethasone for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination of treatments to assess their safety and tolerability for people with multiple myeloma that has returned or not responded to previous treatments. The focus is on using selinexor (a potential new drug), carfilzomib, isatuximab, and dexamethasone together. The trial seeks participants who have tried at least one previous treatment for multiple myeloma and still show measurable signs of the disease. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications that affect the liver enzyme CYP3A4, like some antibiotics and herbal supplements, within 7 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of selinexor, carfilzomib, isatuximab, and dexamethasone appears safe. Studies have found that treatments using isatuximab are usually well-tolerated and effective. Specifically, when combined with other treatments, isatuximab can be safely administered using a special delivery system worn on the body.
Other research indicates that selinexor, when used with carfilzomib and dexamethasone, is generally safe for patients with multiple myeloma. However, these treatments can have side effects, and the specific combination under study is still being tested for safety.
The trial phase means the treatment is still being tested in humans, so while the results are promising, they are not yet final. Always consult healthcare providers when considering participation in a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Selinexor, Carfilzomib, Isatuximab, and Dexamethasone for multiple myeloma because it offers a novel approach by combining multiple mechanisms of action. Unlike standard treatments that often focus on a single pathway, this regimen combines Selinexor's unique ability to block cancer cells' survival signals with Carfilzomib's and Isatuximab’s targeted actions against the cancer cells themselves. This innovative blend aims to enhance treatment effectiveness and overcome resistance seen in conventional therapies. Additionally, the combination's potential to be administered both orally and intravenously provides flexibility in treatment delivery, potentially improving patient outcomes and quality of life.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that a combination of four drugs—selinexor, carfilzomib, isatuximab, and dexamethasone—may help treat multiple myeloma, a type of blood cancer. One study found that 78% of patients with relapsed or hard-to-treat multiple myeloma responded to this treatment, with 44% experiencing a very good reduction in cancer activity. This indicates that many patients saw a significant decrease in their cancer. Another study demonstrated that selinexor can help myeloma cells that stopped responding to treatment become sensitive again. The success of these drugs in other situations supports their potential in this trial, where participants will receive the combination of selinexor, carfilzomib, isatuximab, and dexamethasone.14678
Who Is on the Research Team?
Natalie Callander, MD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for adults (18+) with multiple myeloma that has come back or not responded to treatment, who have had at least one prior therapy. Patients must be able to perform daily activities and meet certain lab criteria. Those recently treated with anti-CD38 drugs or refractory to both daratumumab and carfilzomib can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase Ib Treatment
Safety run-in with selinexor, carfilzomib, isatuximab, and dexamethasone to determine tolerability and dose adjustments
Phase II Treatment
Testing the Recommended Phase 2 Dose (RP2D) in an expansion cohort with selinexor, carfilzomib, isatuximab, and dexamethasone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carfilzomib
- Dexamethasone
- Isatuximab
- Selinexor
Trial Overview
The study tests a combination of four drugs—selinexor, carfilzomib, isatuximab (including a wearable injection system), and dexamethasone—in people with relapsed/refractory multiple myeloma. The trial first checks safety in a small group before expanding to more patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive selinexor at their assigned dose taken orally on a 28-day cycle combined with carfilzomib, isatuximab, and dexamethasone IV administered on a 28-day cycle until disease progression or for an unacceptable toxicity.
Participants will receive selinexor at their assigned dose taken orally on a 28-day cycle combined with carfilzomib, isatuximab, and dexamethasone IV administered on a 28-day cycle until disease progression or for an unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Natalie Callander
Lead Sponsor
Sanofi
Industry Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
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
University of Wisconsin, Madison
Collaborator
Citations
Updated results from phase 2b study of selinexor in ...
This trial demonstrates that selinexor can restore sensitivity to regimens to which MM patients are actively refractory.
NCT07479979 | Study of Selinexor With Carfilzomib ...
The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS** and ...
Real-World Treatment Patterns and Survival Outcomes ... - PMC
These data suggest that, in the real-world setting, the use of selinexor triplet regimens is effective in patients with RRMM, especially those ...
Selinexor-Based Triplet Regimens in Patients With Multiple ...
We analyzed the efficacy and safety of selinexor-based triplets (selinexor+dexamethasone [Sd] plus pomalidomide [SPd, n = 23], bortezomib [SVd, n = 16] or ...
5.
valuebasedcancer.com
valuebasedcancer.com/issues/2019/december-2019-vol-10-no-6/selinexor-dexamethasone-combination-improves-outcomes-in-patients-with-multiple-myeloma-refractory-to-3-drug-classesSelinexor-Dexamethasone Combination Improves ...
The median duration of response was 4.4 months, the median progression-free survival was 3.7 months, and the median overall survival was 8.6 months. Patients ...
Efficacy and Safety of Isatuximab Combination Therapy in ...
The analysis of response rates revealed that isatuximab-based therapy was associated with improved depth of response across multiple endpoints.
Efficacy and safety of isatuximab subcutaneous (SC) plus ...
The study met its primary endpoint, demonstrating efficacy and safety of Isa SC administration in combination with Kd, either by manual injection or OBDS.
Selinexor in Combination with Carfilzomib, Subcutaneous ...
This phase Ib/II trial tests the safety, side effects, and effectiveness of selinexor in combination with carfilzomib, isatuximab given beneath the skin ...
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