Multiple MyelomaPhase 1NCT07200102
Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
A Phase 1 study testing Selinexor in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The outcomes in patients with relapsed or refractory multiple myeloma refractory to triple-therapy remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Selinexor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 31 Mar 2031
- Phase
- Phase 1
- 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
- Diagnosed with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. Diagnosis must be histologically confirmed. Patients with multiple myeloma with local amyloid deposition in the bone marrow are eligible. Only the following risk categories will be enrolled:
- High risk myeloma, defined by the presence of at least one of the following features:
- Deletion 17p and/or TP53 alteration:
- Deletion of 17p with a cancer clonal fraction (CCF) ≥20%, assessed on CD138-positive/purified plasma cells, AND/OR
- TP53 mutation identified using a validated next-generation sequencing (NGS)-based assay.
- High-risk IgH translocation with chromosome 1 abnormality:
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- Presence of t(4;14), t(14;16), or t(14;20) in combination with either gain/amplification of 1q (1q+) and/or deletion of 1p32.
- Chromosome 1p32 deletion patterns:
- Monoallelic deletion of 1p32 occurring with gain/amplification of 1q, OR
- Biallelic deletion of 1p32.
- Elevated β2-microglobulin without renal dysfunction:
- Serum β2-microglobulin ≥5.5 mg/L in the setting of normal renal function, defined as serum creatinine <1.2 mg/dL.
- Presence of extramedullary disease prior to receiving CAR-T OR
- Standard risk myeloma with MRD-positive (MRD+) disease at MRD draw around Day 58-60 post CAR-T.
- Received or planning to receive standard of care ciltacabtagene autoleucel (cilta-cel; Carvykti).
- Able to monitor disease response by ClonoSEQ MRD testing.
- At least 18 years of age.
- ECOG performance status ≤ 2.
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 50 K/cumm
- Hemoglobin ≥ 8.5 g/dL without blood transfusion within 7 days before C1D1.
- Total bilirubin ≤ 1.5 x IULN; patients with Gilbert's syndrome must have a total bilirubin < 3 x IULN.
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
- Calculated creatinine clearance ≥ 15 mL/min by Cockcroft-Gault
- The effects of selinexor on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to C1D1 of selinexor, for the duration of study participation, and for 90 days after completion of selinexor. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- MM with active CNS involvement.
- Confirmed progressive disease by IMWG after CAR-T administration.
- Unresolved cytokine release syndrome (CRS) or CAR-T neurologic toxicity.
- Any unresolved non-hematologic grade ≥ 3 treatment-related toxicity from CAR-T.
- Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma from Day 28 post-CAR-T cell therapy through discontinuation from study treatment. Note: patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis)
- Has received selinexor or another XPO1 inhibitor post-CART.
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- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Prior organ transplant requiring immunosuppressive therapy.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor or other agents used in the study.
- Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1 of selinexor (patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 of selinexor may enroll); active, unstable cardiovascular function, as indicated by the presence of symptomatic ischemia, uncontrolled clinically significant conduction abnormalities (e.g. patients with ventricular or atrial tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), congestive heart failure of NYHA class ≥ 3 or known left ventricular ejection fraction of < 40%, or myocardial infraction within 3 months prior to C1D1 of selinexor therapy.
- Major surgery within 28 days prior to C1D1 of selinexor
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of C1D1 of selinexor.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
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
Washington University School of Medicine
St Louis, Missouri, 63110
Mark A Schroeder, M.D., 314-454-8306, markschroeder@wustl.edu
Mark A Schroeder, M.D.
About this study
The outcomes in patients with relapsed or refractory multiple myeloma refractory to triple-therapy remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). BCMA CAR-T therapy is not curative, and unlike autologous stem cell transplant, there is currently no standard for maintenance therapy post CAR-T which could potentially increase MRD rates and extend progression-free survival.
Selinexor is an exportin (XPO1) inhibitor with direct anti-tumor effect used often as an adjunct with other agents as bridging therapy prior to CAR-T. As selinexor does not affect T-cell yields or fitness, T-cell collection on selinexor for CAR-T manufacturing is safe.
The aim of this study is to evaluate the safety and toxicity of selinexor in relapsed or refractory multiple myeloma patients with high-risk features (adverse risk cytogenetics, less than complete response (CR) post CAR-T, or extramedullary disease) following BCMA CAR-T therapy. The investigators hypothesize that selinexor as maintenance therapy following CAR-T has the potential to act synergistically with CAR-T cells leading to more durable responses.
- Conditions
- Multiple Myeloma
- Being tested
- Selinexor
- Keywords
- Cilta-cel, Selinexor, Multiple Myeloma, Maintenance
- 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
Also called KPT-330, Xpovio
Selinexor will be provided by Karyopharm Therapeutics, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Selinexor | Experimental | Patients with high risk of relapse will receive maintenance selinexor starting at Day 30 (high risk MM patients) or after Day 58 (for MRD+ patients) post-cilta-cel infusion and will continue selinexor for up to 12 cycles. Selinexor will be given weekly on Days 1, 8, 15, and 22 of each 28-day cycle. The first 3 to 6 patients enrolled will be part of the safety run-in cohort; these patients will be monitored for dose-limiting toxicities during Cycle 1. Receives: Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of non-hematologic grade ≥ 3 treatment-related adverse events (excluding conditioning and CAR-T related adverse events) according to CTCAE v 6.0
Measured: From start of selinexor through 30 days after the last dose of selinexor (estimated to be 13 months)
Tolerability as measured by rate of patients who received > 80% of cumulative selinexor dose during the study period
Measured: Through completion of selinexor treatment (estimated to be 12 months)
Secondary outcomes (8)
Rate of MRD negativity by clonoSEQ sensitive to 10-5
Measured: At 6 months after CAR-T infusion
Rate of MRD negativity by clonoSEQ sensitive to 10-5
Measured: At 12 months after CAR-T infusion
Rate of complete response (CR) and stringent CR (sCR) by IMWG response criteria
- sCR: Stringent complete response requires all of the following:
- CR as defined below
- Normal free light chain ratio (0.26-1.65)
- Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
- CR: Complete response requires all of the following:
- Negative immunofixation on the serum and urine
- Normal free light chain ratio (0.26-1.65)
- <5% plasma cells in the bone marrow aspirate
- Disappearance of any soft tissue plasmacytomas
Measured: At 6 months after CAR-T infusion
Rate of complete response (CR) and stringent CR (sCR) by IMWG response criteria
- sCR: Stringent complete response requires all of the following:
- CR as defined below
- Normal free light chain ratio (0.26-1.65)
- Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
- CR: Complete response requires all of the following:
- Negative immunofixation on the serum and urine
- Normal free light chain ratio (0.26-1.65)
- <5% plasma cells in the bone marrow aspirate
- Disappearance of any soft tissue plasmacytomas
Measured: At 12 months after CAR-T infusion
Progression-free survival (PFS)
PFS is defined as: The time from initiation of treatment to the occurrence of either objective disease progression (by IMWG criteria) or death from any cause, whichever comes first.
Measured: At 6 months after CAR-T infusion
Progression-free survival (PFS)
PFS is defined as: The time from initiation of treatment to the occurrence of either objective disease progression (by IMWG criteria) or death from any cause, whichever comes first.
Measured: At 12 months after CAR-T infusion
Time to progression (TTP)
TTP is defined as: The interval from initiation of therapy to the first documentation of disease progression, as determined by IMWG criteria.
Measured: Through completion of follow-up (estimated to be 24 months)
Duration of response (DOR)
DOR is defined as: The time interval from the first documented evidence of a partial response or better after starting treatment by IMWG criteria to the occurrence of disease progression (by IMWG criteria) or death from any cause.
Measured: Through completion of follow-up (estimated to be 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start17 Mar 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Responsible party
- Sponsor
- Investigators
- Mark A Schroeder, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200102
- Sponsor's protocol ID
- 202511028
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07200102
- Acronym / sponsor ID
- 202511028
- Conditions
- Multiple Myeloma
- Keywords
- Cilta-cel, Selinexor, Multiple Myeloma, Maintenance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 30 Sep 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 outcomes in patients with relapsed or refractory multiple myeloma refractory to triple-therapy remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). BCMA CAR-T therapy is not curative, and unlike autologous stem cell transplant, there is currently no standard for maintenance therapy post CAR-T which could potentially increase MRD rates and extend progression-free survival.
Selinexor is an exportin (XPO1) inhibitor with direct anti-tumor effect used often as an adjunct with other agents as bridging therapy prior to CAR-T. As selinexor does not affect T-cell yields or fitness, T-cell collection on selinexor for CAR-T manufacturing is safe.
The aim of this study is to evaluate the safety and toxicity of selinexor in relapsed or refractory multiple myeloma patients with high-risk features (adverse risk cytogenetics, less than complete response (CR) post CAR-T, or extramedullary disease) following BCMA CAR-T therapy. The investigators hypothesize that selinexor as maintenance therapy following CAR-T has the potential to act synergistically with CAR-T cells leading to more durable responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexor | Experimental | Drug: SelinexorPatients with high risk of relapse will receive maintenance selinexor starting at Day 30 (high risk MM patients) or after Day 58 (for MRD+ patients) post-cilta-cel infusion and will continue selinexor for up to 12 cycles. Selinexor will be given weekly on Days 1, 8, 15, and 22 of each 28-day cycle. The first 3 to 6 patients enrolled will be part of the safety run-in cohort; these patients will be monitored for dose-limiting toxicities during Cycle 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Diagnosed with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. Diagnosis must be histologically confirmed. Patients with multiple myeloma with local amyloid deposition in the bone marrow are eligible. Only the following risk categories will be enrolled:
- Received or planning to receive standard of care ciltacabtagene autoleucel (cilta-cel; Carvykti).
- Able to monitor disease response by ClonoSEQ MRD testing.
- At least 18 years of age.
- ECOG performance status ≤ 2.
Key exclusion criteria (18 listed)
- MM with active CNS involvement.
- Confirmed progressive disease by IMWG after CAR-T administration.
- Unresolved cytokine release syndrome (CRS) or CAR-T neurologic toxicity.
- Any unresolved non-hematologic grade ≥ 3 treatment-related toxicity from CAR-T.
- Administration or planned administration of any other concomitant chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy which would be considered a treatment of multiple myeloma from Day 28 post-CAR-T cell therapy through discontinuation from study treatment. Note: patients may be on corticosteroids if they are being given for disorders other than multiple myeloma (e.g., adrenal insufficiency, rheumatoid arthritis)
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 |
|---|---|---|
| SelinexorAlso: KPT-330, XpovioSelinexor will be provided by Karyopharm Therapeutics, Inc. | Drug | Selinexor |
Primary outcome
Rate of non-hematologic grade ≥ 3 treatment-related adverse events (excluding conditioning and CAR-T related adverse events) according to CTCAE v 6.0
Time frame: From start of selinexor through 30 days after the last dose of selinexor (estimated to be 13 months)
Tolerability as measured by rate of patients who received > 80% of cumulative selinexor dose during the study period
Time frame: Through completion of selinexor treatment (estimated to be 12 months)
8 secondary outcomes
Rate of MRD negativity by clonoSEQ sensitive to 10-5
Time frame: At 6 months after CAR-T infusion
Rate of MRD negativity by clonoSEQ sensitive to 10-5
Time frame: At 12 months after CAR-T infusion
Rate of complete response (CR) and stringent CR (sCR) by IMWG response criteria
Time frame: At 6 months after CAR-T infusion
Rate of complete response (CR) and stringent CR (sCR) by IMWG response criteria
Time frame: At 12 months after CAR-T infusion
Progression-free survival (PFS)
Time frame: At 6 months after CAR-T infusion
Progression-free survival (PFS)
Time frame: At 12 months after CAR-T infusion
Time to progression (TTP)
Time frame: Through completion of follow-up (estimated to be 24 months)
Duration of response (DOR)
Time frame: Through completion of follow-up (estimated to be 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 15 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported after deidentification
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A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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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.
Mark A Schroeder, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selinexor in people with Multiple Myeloma, run by Washington University School of Medicine 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 27 inclusion and 18 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 15 Oct 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 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.
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 Mark A Schroeder, M.D. (314-454-8306, markschroeder@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of non-hematologic grade ≥ 3 treatment-related adverse events (excluding conditioning and CAR-T related adverse events) according to CTCAE v 6.0 (time frame: From start of selinexor through 30 days after the last dose of selinexor (estimated to be 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 15 Oct 2026.