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Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

NCT07479979•Natalie Callander

View on ClinicalTrials.gov

Summary

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 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 RP2D in an expansion cohort of up to 50 patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•2. Age ≥ 18 years at the time of consent.
•3. ECOG Performance Status of ≤2 within 28 days prior to registration. A performance status of \>2 will be allowed only if it is related to bone pain that is expected to improve with treatment.
•4. Patients with a diagnosis of relapsed or relapsed/refractory MM who have received at least 1 line of prior therapy. In the phase 2 component, we will specifically enrich for patients with high-risk features with the aim of including ≥50% of the enrolled population (a minimum of 25 patients) with high risk disease. High risk disease is defined as the presence of R-ISS 3, gain/amp 1q21 or t(4;14), t(14;16), p53 deletion, 1q21 gain/amp as defined by FISH and/or cytogenetic analysis. For purposes of the study, ultrahigh risk MM will be defined as 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:
•1. A monoclonal protein (M-protein): ≥ 0.5g/dL on serum protein electrophoresis or ≥ 200 mg of monoclonal protein on a 24-hour urine protein or involved serum light chain ≥ 10 mg/dl at time of relapse, or
•2. Biopsy proven plasmacytoma that can be assessed by physical exam or imaging, or
•3. If non- or oligo secretory, ≥10% plasma cells on BM biopsy/aspirate at time of relapse or plasmacytoma as described and/or evaluable disease by positron emission tomography, either MR or CT. Patients must be willing to undergo repeat BM aspirate and biopsy to assess response.
•4. Due to the difficulty of quantitation using conventional SPEP of IgA and IgD monoclonal proteins, an absolute increase of \> 25 % over previous nadir will meet eligibility requirements for progression and study eligibility.
•NOTE: Urine protein electrophoresis (UPEP) (on a 24-h collection) is required at baseline; no substitute method is acceptable. Urine must be assessed to establish response if the baseline urine M-spike is ≥ 200 mg/24 h. Please note that if both serum and urine M-components are present prior to transplant, both should be assessed in order to evaluate response for CR. For patients without a monoclonal urine protein ≥200mg/24 hours, the test only needs to be repeated to corroborate CR.
+19 more criteria

Exclusion Criteria

•1. Active infection requiring systemic therapy (Note: subjects can be enrolled if they will be completing antibiotic therapy by the time of actual start date of treatment)
•2. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
•3. Known additional malignancy that is active and/or progressive, requiring urgent or new treatment. Exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, prostate cancer on stable hormonal therapy, DCIS or other cancer for which the subject has been disease-free for at least three years. Patients who have undergone a curative procedure for another malignancy are eligible.
•4. Active central nervous system (CNS) metastases. NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases.
•5. History of severe hypersensitivity reaction (grade 3 or more) to an anti-CD38 antibody that in the opinion of the investigator excludes the use of these drugs.
•6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III and IV), unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•7. Treatment with any investigational drug within 14 days prior to registration.
•8. Any previously active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment. This is likely to be a rare occurrence.
•9. Treatment with moderate or strong inhibitors/inducers of CYP3A within 7 days prior to Day 1 of Cycle 1. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, and St. John's Wort. For patients receiving diltiazem or verapamil, alternative therapy will need to be substituted, if necessary, if the drug cannot otherwise be safely discontinued.
•10. Currently receiving a strong CYP3A4 inhibitor/inducer and unable to discontinue such medications.
+5 more criteria

Key Dates

Start Date

July 1, 2026

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2029

Last Updated

March 18, 2026

Enrollment

ESTIMATED participants

Conditions

Relapse Multiple MyelomaRefractory Multiple Myeloma

Interventions

Selinexor

DRUG

Carfilzomib

DRUG

Isatuximab

DRUG

Isatuximab SC Wearable Injection System

DEVICE

Dexamethasone

DRUG

Contacts

Natalie Callander, MD

CONTACT

608-265-8690 nsc@medicine.wisc.edu

Ahran Lee

CONTACT

317-634-5842 alee@hoosiercancer.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Elranatamab in R/R Multiple Myeloma

A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)