62 Participants NeededMy employer runs this trial

Selinexor + Carfilzomib + Isatuximab + Dexamethasone for Multiple Myeloma

NC
AL
Overseen ByAhran Lee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

NC

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

I have not had anti-CD38 therapy in the past 6 months.
I have had a donor transplant and am not on treatment for graft-versus-host disease.
1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Safety run-in with selinexor, carfilzomib, isatuximab, and dexamethasone to determine tolerability and dose adjustments

28-day cycles until disease progression or unacceptable toxicity
Regular visits as per 28-day cycle

Phase II Treatment

Testing the Recommended Phase 2 Dose (RP2D) in an expansion cohort with selinexor, carfilzomib, isatuximab, and dexamethasone

28-day cycles until disease progression or unacceptable toxicity
Regular visits as per 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person) at 30-day safety follow-up

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

Group I: Phase 2: Selinexor, Carfilzomib, Isatuximab, and DexamethasoneExperimental Treatment5 Interventions
Group II: Phase 1: Selinexor, Carfilzomib, Isatuximab, and DexamethasoneExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Natalie Callander

Lead Sponsor

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Karyopharm Therapeutics Inc

Industry Sponsor

Trials
89
Recruited
7,200+

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

Trials
1,249
Recruited
3,255,000+

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 ...

Selinexor-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 ...