Actively Recruiting
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
Led by Natalie Callander · Updated on 2026-05-14
62
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
Natalie Callander
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.
CONDITIONS
Official Title
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Be at least 18 years old
- Have an ECOG Performance Status of 2 or less within 28 days before registration (higher allowed if due to bone pain expected to improve)
- Diagnosed with relapsed or relapsed/refractory multiple myeloma and have received at least one prior therapy
- Have measurable disease by monoclonal protein levels, biopsy, or plasma cell percentage as defined
- May have received any previous treatments including carfilzomib and anti-CD38 antibodies, but not refractory to daratumumab and carfilzomib combination
- No anti-CD38 therapy within 6 months before study treatment start
- Previous allogeneic transplant allowed if no ongoing graft-versus-host disease therapy
- Previous BCMA-directed or T cell redirecting therapies allowed if no residual severe side effects
- Adequate organ function based on blood counts, kidney and liver tests within 28 days before registration
- Females of childbearing potential must have a negative pregnancy test and agree to contraception during and after study
- Males able to father a child must agree to contraception during and after study and not donate sperm
- Able to understand and comply with study procedures
- Patients with controlled HIV or hepatitis B or C infection may participate if viral loads are undetectable
- Willing to provide bone marrow biopsy and blood samples for research
You will not qualify if you...
- Active infection needing systemic treatment (may enroll if antibiotics will be completed by treatment start)
- Pregnant or breastfeeding
- Active or progressive additional cancers requiring urgent treatment, with certain exceptions
- Active central nervous system metastases
- History of severe allergic reaction to anti-CD38 antibodies
- Uncontrolled illnesses including heart failure, unstable angina, arrhythmia, or psychiatric/social issues affecting compliance
- Use of investigational drugs within 14 days before registration
- Gastrointestinal problems preventing swallowing or absorption of study drugs
- Use of moderate or strong CYP3A inhibitors or inducers within 7 days before treatment start, or inability to discontinue them
- Prior use of SINE compounds including selinexor
- Anti-CD38 therapy within 6 months of registration
- Cardiac imaging showing left ventricular ejection fraction below 40% within 60 days before registration
- Presence of plasma cell leukemia
- History of POEMS syndrome or primary AL amyloidosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
N
Natalie Callander, MD
CONTACT
A
Ahran Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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