Relapse Multiple MyelomaPhase 1/2NCT07479979
Study of Selinexor With Carfilzomib, Isatuximab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1/2 study testing Selinexor, Carfilzomib and Isatuximab in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Natalie Callander at 1 site in United States.
Trial 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 (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Selinexor, Carfilzomib and Isatuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2026to Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Age ≥ 18 years at the time of consent.
- 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.
- 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 1q gain or amplification as well as other IMWG 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:
- 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)
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- 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.
- Patients must have measurable disease as defined by at least one of the following:
- 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
- Biopsy proven plasmacytoma that can be assessed by physical exam or imaging, or
- 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.
- Due to the difficulty of quantitation using conventional SPEP of IgA and IgD monoclonal proteins, an absolute increase of > 25 % over previous nadir of the total values in mg/dl (or adjusted units) 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 at the time of enrollment, both should be assessed in order to evaluate response for CR but monthly 24 hour urine tests outside of this response testing are not necessary. For patients without a monoclonal urine protein ≥200mg/24 hours, the test only needs to be repeated to corroborate CR.
- Patients may have received any number and type of previous treatments for myeloma including carfilzomib and an anti-CD38 antibody but cannot be refractory to the combination of daratumumab and carfilzomib.
- Patients may not have received any anti-CD38 therapy within 6 months of start of study treatment (not enrollment).
- Previous allogeneic transplant is allowed provided the patient is not receiving ongoing systemic therapy for graft-versus-host disease (GVHD).
- Previous B-cell maturation antigen (BCMA)-directed therapy, including chimeric antigen receptor T-cell therapy (CAR-T) transplantation, antibody drug conjugates, or bispecific engagers is also allowed, provided there is no evidence of residual cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome. In addition, other T cell redirecting therapy exposure is permitted as well.
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
- 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
- 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.
- 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.
- 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
- 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.
- 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.
- Subject willing to provide mandatory bone marrow biopsy and peripheral blood laboratory testing for research purposes only.
Who cannot join
- 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)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- 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.
- 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.
- 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.
- 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.
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- Treatment with any investigational drug within 14 days prior to registration.
- 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.
- 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.
- Currently receiving a strong CYP3A4 inhibitor/inducer and unable to discontinue such medications.
- Prior exposure to a SINE compound, including selinexor.
- Exposure to anti-CD38 directed therapy (ex. daratumumab; isatuximab; daratumumab/hyaluronidase) within 6 months of study registration.
- Patients with an echocardiogram or other cardiac imaging study showing a LVEF of <40% within 60 days of study registration.
- Presence of plasma cell leukemia at time of registration
- Patients with a history of POEMS syndrome or primary AL amyloidosis are excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Beth Moore, 608-262-5189, bmmoore2@wisc.edu
About this study
Official title: 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
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.
- Being tested
- Selinexor, Carfilzomib, Isatuximab, Isatuximab SC Wearable Injection System, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Phase I: Selinexor at assigned dose by mouth begin Day 1, 8, 15, and 22 until study treatment stop. - Dose Levels: -1: 20mg weekly 0 (Starting Dose): 40mg weekly 1: 60mg weekly
Phase II: Selinexor at assigned dose by mouth based on the phase 1 findings. Selinexor will be taken weekly (Days 1, 8, 15, and 22).
CarfilzomibDrug
Phase I and Phase II: Carfilzomib IV will be administered on Day 1, 8, and 15. The first dose of carfilzomib will be carfilzomib 20mg/m2 IV. Every dose after will be carfilzomib 56mg/m2.
IsatuximabDrug
Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
Isatuximab SC Wearable Injection SystemDevice
Phase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15.
DexamethasoneDrug
Phase I and Phase II: Dexamethasone 40mg will be administered either by IV or orally on Days 1, 8, 15, and 22.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone | Experimental | 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. Receives: Drug: Selinexor; Drug: Carfilzomib; Drug: Isatuximab; Device: Isatuximab SC Wearable Injection System; Drug: Dexamethasone |
| Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone | Experimental | 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. Receives: Drug: Selinexor; Drug: Carfilzomib; Drug: Isatuximab; Device: Isatuximab SC Wearable Injection System; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
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.
Measured: 24 months
Secondary outcomes (7)
Progression-free Survival (PFS)
PFS will be calculated from the date of start of study therapy to the date of progression based on International Myeloma Working Group (IMWG) criteria, or date of death due to any cause should progression not have occurred.
Measured: 24 months
Overall Response Rate (ORR)
ORR will include confirmed stringent complete response (sCR), confirmed complete response (CR), confirmed very good partial response (VGPR), and confirmed partial response (PR), and will be determined as per IMWG criteria.
Measured: 24 months
Minimal Residual Disease (MRD) Rate
MRD will be assessed by multiparametric flow cytometry and/or next-generation sequencing (NGS).
Measured: 24 months
Progression-free Survival (PFS) in subgroup population
Comparison of PFS between patients previously exposed to anti-CD38 therapy and those naïve/exposed but not refractory to the combination of carfilzomib and daratumumab will be made by subgroup analysis.
Measured: 24 months
Overall Response Rate (ORR) in subgroup population
Comparison of ORR between patients previously exposed to anti-CD38 therapy and those naïve/exposed but not refractory to the combination of carfilzomib and daratumumab will be made by subgroup analysis.
Measured: 24 months
Minimal Residual Disease (MRD) in subgroup population
Comparison of MRD between patients previously exposed to anti-CD38 therapy and those naïve/exposed but not refractory to the combination of carfilzomib and daratumumab will be made by subgroup analysis.
Measured: 24 months
Quality of Life (QOL)
Changes in quality of life, as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 and Patient-Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE), administered at baseline, every other cycle of completed therapy, and at the 30-day safety follow up visit.
PROMISE-29: Each question usually has five response options ranging in value from 1 (Not at All) to 5 (Very Much). Minimum score for the questionnaire is 28 and the maximum score is 150. The raw score is converted into a T-score. A higher PROMIS T-score represents more of the concept being measured.
PRO-CTCAE: Responses are scored from 0 to 4 (or 0/1 for absent/present). The fields chosen are specific to this study. The minimum score for the questionnaire is 0 and the maximum score is 151. Respondents are also allowed to write in any additional symptoms and rate them from 0 to 4. At present there are no guidelines established for how to combine attributes into a single score.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start21 May 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalie Callander
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Karyopharm Therapeutics Inc, University of Wisconsin, Madison
- Responsible party
- Sponsor-investigator, Natalie Callander, Hoosier Cancer Research Network
- Investigators
- Natalie Callander, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479979
- Sponsor's protocol ID
- BTCRC-MM21-528
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07479979
- Acronym / sponsor ID
- BTCRC-MM21-528
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Natalie CallanderUniversity, hospital or other
- Collaborators
- Sanofi, Karyopharm Therapeutics Inc, University of Wisconsin, Madison
- Study start
- 21 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone | Experimental | Drug: Selinexor, Drug: Carfilzomib, Drug: Isatuximab, Device: Isatuximab SC Wearable Injection System, Drug: DexamethasoneParticipants 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. |
| Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone | Experimental | Drug: Selinexor, Drug: Carfilzomib, Drug: Isatuximab, Device: Isatuximab SC Wearable Injection System, Drug: DexamethasoneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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.
- Age ≥ 18 years at the time of consent.
- 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.
- 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 1q gain or amplification as well as other IMWG 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:
- Patients must have measurable disease as defined by at least one of the following:
Key exclusion criteria (15 listed)
- 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)
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelinexorPhase I: Selinexor at assigned dose by mouth begin Day 1, 8, 15, and 22 until study treatment stop. - Dose Levels: -1: 20mg weekly 0 (Starting Dose): 40mg weekly 1: 60mg weekly Phase II: Selinexor at assigned dose by mouth based on the phase 1 findings. Selinexor will be taken weekly (Days 1, 8, 15, and 22). | Drug | Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone |
| CarfilzomibPhase I and Phase II: Carfilzomib IV will be administered on Day 1, 8, and 15. The first dose of carfilzomib will be carfilzomib 20mg/m2 IV. Every dose after will be carfilzomib 56mg/m2. | Drug | Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone |
| IsatuximabPhase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15. | Drug | Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone |
| Isatuximab SC Wearable Injection SystemPhase I and Phase II: Isatuximab 1400mg will be administered by injection from the wearable device. For the first 28 days isatuximab will be administered on days 1, 8, 15, and 22. For every cycle after isatuximab will be administered on days 1 and 15. | Device | Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone |
| DexamethasonePhase I and Phase II: Dexamethasone 40mg will be administered either by IV or orally on Days 1, 8, 15, and 22. | Drug | Phase 1: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone, Phase 2: Selinexor, Carfilzomib, Isatuximab, and Dexamethasone |
Primary outcome
Adverse Events
Time frame: 24 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.
7 secondary outcomes
Progression-free Survival (PFS)
Time frame: 24 months
Overall Response Rate (ORR)
Time frame: 24 months
Minimal Residual Disease (MRD) Rate
Time frame: 24 months
Progression-free Survival (PFS) in subgroup population
Time frame: 24 months
Overall Response Rate (ORR) in subgroup population
Time frame: 24 months
Minimal Residual Disease (MRD) in subgroup population
Time frame: 24 months
Quality of Life (QOL)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Callander, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Selinexor, Carfilzomib and Isatuximab in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Natalie Callander at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Callander, MD (608-265-8690, nsc@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.