Multiple Myeloma in RelapsePhase 2NCT06822972
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
A Phase 2 study testing Selinexor 40 mg in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Duke University at 1 site in United States.
Trial summary
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
- What is being tested?
- Selinexor 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 31 Dec 2027
- Phase
- Phase 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
- Age ≥ 18 years old at the time of informed consent.
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.
- All patients must meet criteria for and will receive teclistamab, elranatamab or talquetamab, as per approved label dosing.
- Patients who have had CRS/ICANS from bispecific antibody must have complete resolution of CRS/ICANS before initiation of SEL
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- Measurable disease as defined by at least one of the following:
- Serum monoclonal (M) protein ≥1.0 g/dl by protein electrophoresis
- >200 mg of M protein in the urine on 24 hour electrophoresis
- Serum immunoglobulin free light chain ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Measurable plasmacytoma
- Adequate hepatic function measured on labs collected within 28 days of C1D1:
- Total bilirubin <1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of <3 × ULN), and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) normal to <2.5 × ULN.
- Adequate renal function measured on labs collected within 28 days of C1D1. Adequacy will be determined by creatinine clearance with values of ≥ 15 mL/min meeting inclusion criteria. Creatinine Clearance will be calculated using the Cockcroft and Gault formula [(140 - Age) x Mass (kg)/ (72 x creatinine mg/dL); multiply by 0.85 if female] (Cockcroft 1976).
- Adequate hematopoietic function measured on labs collected within 7 days of C1D1:
- Absolute neutrophil count ≥1500/mm3
- Hemoglobin ≥8.5 g/dL
- Platelet count ≥100,000/mm3 (patients for whom <50% of bone marrow nucleated cells are plasma cells) or ≥50,000/mm3 (patients for whom ≥50% of bone marrow nucleated cells are plasma cells)
- Note 1: Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (e.g., eltrombopag, romiplostim, interleukin-11) are eligible.
- Note 2: Patients must have at least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
- Patients who are able to become pregnant must have a negative serum pregnancy test at screening.
- All patients who could become pregnant or could father a child must use highly effective methods of contraception throughout the study and for 5 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 9.3.1.
- Female patients must agree not to donate egg during the study treatment period and/or up to 90 days after the last dose of Selinexor. Male patients must agree not to donate sperm during the study treatment period and/or up to 90 days after the last dose of Selinexor.
Who cannot join
- Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
- Patients with any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection) that is likely to interfere with study procedures.
- Patients with any uncontrolled active infection requiring medical or surgical management within 1 week prior to Cycle 1 Day 1 (C1D1). Note: Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are eligible.
- Females who are pregnant or breastfeeding females.
- Patients with active, unstable cardiovascular function, as indicated by the presence of any of the following:
- Symptomatic ischemia
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- Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmics); note: patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block are eligible
- Congestive heart failure of New York Heart Association Class ≥3
- Known left ventricular ejection fraction <40%
- Myocardial infarction within 3 months prior to C1D1.
- Patients with well controlled chronic viral hepatitis and/or Human Immunodeficiency Virus can be considered for the study if they meet any of the following conditions:
- Patients with active hepatitis B virus (Hep B) who have been on antiviral therapy for hepatitis B for >8 weeks and whose viral load is <100 IU/ml prior to first dose of trial treatment
- Patients with treated or untreated hepatitis C virus (HCV) and successfully treated and "cured" HCV
- Patients with Human Immunodeficiency Virus (HIV) who have CD4+ T-cell counts ≥ 350 cells/µL and no history of AIDS-defining opportunistic infections in the last year
- Patients who still have any grade of CRS/ICANS at 5 (± 2) days of administration of the first full treatment dose of bispecific antibody treatment will be excluded
- Patients with any active gastrointestinal dysfunction interfering with their ability to swallow tablets or any active gastrointestinal dysfunction that could interfere with absorption of study treatment
- Patients who are unable or unwilling to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care)
- Patients who have any psychiatric, medical, or other condition that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Patients with contraindication to any of the required concomitant drugs or supportive treatments
- Patients unwilling or unable to comply with the protocol
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
Duke University Health System
Durham, North Carolina, 27705
Jennifer Tichon, 919-660-7262, jennifer.tichon@duke.edu
About this study
Official title: A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
- Being tested
- Selinexor 40 mg
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexor 40 mgDrug
Patients will receive 40mg of oral SEL, weekly, beginning after they have completed step-up dosing and are 5 (± 2) days out from administration of the first full treatment dose of bispecific antibody therapy for 12 months or until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Selinexor + bispecific antibody | Experimental | Not described Receives: Drug: Selinexor 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of selinexor given with commercial bispecific antibody as measured by severity of adverse events
Adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: up to 13 months
Minimal residual disease (MRD) negativity rate post bispecific antibody therapy
MRD at 10^-5 will be performed by Clonoseq (Adaptive Biotechnologies) or, if Clonoseq could not be performed due to inability to obtain/identify original plasma cell clone, by Duke institutional flow cytometry-based MRD assay.
Measured: up to 12 months
Secondary outcomes (9)
Overall response rate (ORR)
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Measured: up to 13 months
Complete remission (CR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Measured: up to 13 months
Very good partial response (VGPR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Measured: up to 13 months
Partial response (PR) rate
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Measured: up to 13 months
Progression free survival (PFS)
Disease response will be assessed according to the International Myeloma Working Group (IMWG) response criteria
Measured: up to 13 months
Number of participants with cytokine release syndrome (CRS)
Cytokine release syndrome will be graded according to the Lee criteria for CRS
Measured: up to 13 months
Grade of cytokine release syndrome (CRS)
Cytokine release syndrome will be graded according to the Lee criteria for CRS
Measured: up to 13 months
Number of participants with immune effector cell associated neurotoxicities (ICANS)
Cytokine release syndrome will be graded according to the Lee criteria for CRS
Measured: up to 13 months
Grade of immune effector cell associated neurotoxicities (ICANS)
Cytokine release syndrome will be graded according to the Lee criteria for CRS
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start22 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yubin Kang, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822972
- Sponsor's protocol ID
- Pro00115964
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06822972
- Acronym / sponsor ID
- Pro00115964
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2025 (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 objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy.
The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken.
Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor + bispecific antibody | Experimental | Drug: Selinexor 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years old at the time of informed consent.
- Willing and able to provide written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- A diagnosis of symptomatic multiple myeloma, with relapsed or refractory disease. Patients must have received at least 4 prior lines of therapy. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory agent, and an CD38 monoclonal antibody, and may include treatment with BCMA antibody conjugates or BCMA directed chimeric antigen receptor (CAR) T cell therapy.
- All patients must meet criteria for and will receive teclistamab, elranatamab or talquetamab, as per approved label dosing.
Key exclusion criteria (20 listed)
- Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
- Patients with any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection) that is likely to interfere with study procedures.
- Patients with any uncontrolled active infection requiring medical or surgical management within 1 week prior to Cycle 1 Day 1 (C1D1). Note: Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are eligible.
- Females who are pregnant or breastfeeding females.
- Patients with active, unstable cardiovascular function, as indicated by the presence of any of the following:
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 |
|---|---|---|
| Selinexor 40 mgPatients will receive 40mg of oral SEL, weekly, beginning after they have completed step-up dosing and are 5 (± 2) days out from administration of the first full treatment dose of bispecific antibody therapy for 12 months or until disease progression. | Drug | Selinexor + bispecific antibody |
Primary outcome
Safety of selinexor given with commercial bispecific antibody as measured by severity of adverse events
Time frame: up to 13 months
Adverse events are defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Minimal residual disease (MRD) negativity rate post bispecific antibody therapy
Time frame: up to 12 months
MRD at 10^-5 will be performed by Clonoseq (Adaptive Biotechnologies) or, if Clonoseq could not be performed due to inability to obtain/identify original plasma cell clone, by Duke institutional flow cytometry-based MRD assay.
9 secondary outcomes
Overall response rate (ORR)
Time frame: up to 13 months
Complete remission (CR) rate
Time frame: up to 13 months
Very good partial response (VGPR) rate
Time frame: up to 13 months
Partial response (PR) rate
Time frame: up to 13 months
Progression free survival (PFS)
Time frame: up to 13 months
Number of participants with cytokine release syndrome (CRS)
Time frame: up to 13 months
Grade of cytokine release syndrome (CRS)
Time frame: up to 13 months
Number of participants with immune effector cell associated neurotoxicities (ICANS)
Time frame: up to 13 months
Grade of immune effector cell associated neurotoxicities (ICANS)
Time frame: up to 13 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 3 Sep 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.
Yubin Kang, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selinexor 40 mg in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Duke University 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 24 inclusion and 20 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 3 Sep 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 phase mean?
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 Lauren Hill (9196682369, lauren.hill@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of selinexor given with commercial bispecific antibody as measured by severity of adverse events (time frame: up to 13 months). The study lists 2 primary outcomes in all. 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 3 Sep 2026.