Study of Selinexor, Carfilzomib, Isatuximab, and Dexamethasone for Relapsed/Refractory Multiple Myeloma
This study is testing a combination of four drugs: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, for people with multiple myeloma that has returned or not responded to previous treatments. The main goal is to see how safe this drug combination is and what side effects it might cause. The study will first test different doses of Selinexor in a small group (6-12 people) to find the safest dose. Then, a larger group (up to 50 people) will receive that dose to further evaluate safety. You may be able to join if you are 18 or older and have already received at least one prior treatment for multiple myeloma. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase Ib/II study, meaning it will first find a safe dose of Selinexor and then test that dose in a larger group. It plans to enroll up to 62 participants.
- What's involved
- Selinexor is taken by mouth, Carfilzomib is given intravenously (into a vein), Isatuximab is given by injection from a wearable device, and Dexamethasone is given by IV or orally. The frequency of these treatments varies throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for adverse events (side effects) for 24 months after treatment.
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NCT07479979
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNatalie CallanderInvestigator-initiated
~62 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:SelinexorCarfilzomibIsatuximabIsatuximab SC Wearable Injection SystemDexamethasone
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 24 months
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- Natalie Callander, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
del(17p), with a cutoff of \>20% clonal fraction, and/or TP53 mutation
an IgH translocation including t(4;14), t(14;16), or t(14;20) along with 1q+ and/or del(1p32)
monoallelic del(1p32) along with 1q+ or biallelic del(1p32)
β2 microglobulin ≥5.5 mg/L with normal creatinine (\<1.2 mg/dL) For purposes of the study, patients with 2 or more of these high risk cytogenetic abnormalities. Patients known to carry such abnormalities on previous FISH analysis and/or cytogenetic testing will also be eligible, if results from on-study marrow are unavailable or not obtainable. Therefore, enrollment of patients without these feature(s) will halt once 25 standard risk, non-mutated patients are enrolled and treated. Refractory is defined as patients relapsing on or within 60 days of therapy, per IMWG. 5. Patients must have measurable disease as defined by at least one of the following:
White blood cell (WBC): ≥ 1,500/mm3
Absolute Neutrophil Count (ANC): ≥ 1,000/mm3 a (For subjects with known Duffy null phenotype (benign ethnic neutropenia), the lowest acceptable ANC will be 750/mm3)
Platelet Count: ≥75,000/mm3
Hemoglobin (Hgb): ≥ 8 g/dL
Calculated creatinine clearance: ≥ 20 cc/min using the Cockcroft-Gault formula
Total Bilirubin: ≤ 2 × upper limit of normal (ULN) (except patients with suspected Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of ≤ 3x ULN)
Aspartate aminotransferase (AST): ≤ 3 × ULN
Alanine aminotransferase (ALT): ≤ 3 × ULN 11. Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 7 days prior to registration. 12. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from heterosexual activity or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment, during the study and for 3 months after the last dose of study drug(s). Male participants must agree not to donate sperm during this same time period. 13. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study 14. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with/without active treatment and absolute lymphocyte count is ≥ 350/ul. Such subjects may stay on antiviral therapy during study treatment. 15. Patients with a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection may be enrolled if the viral load by PCR is undetectable with/without active treatment. Such patients may stay on viral therapy while on treatment. Due to a potential HBV and HepC reactivation risk with carfilzomib, the subjects are required to have HBs Ag and HBc Ab screening. 16. Subject willing to provide mandatory bone marrow biopsy and peripheral blood laboratory testing for research purposes only.
What this trial measures
- Adverse Events24 months
Adverse events will be assessed by evaluating Grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.