Multiple Myeloma in RelapsePhase 2NCT04925193
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing Selinexor, Pomalidomide and Daratumumab in people with Multiple Myeloma in Relapse, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- Selinexor, Pomalidomide and Daratumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to Nov 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
- Histologically confirmed diagnosis, measurable disease and evidence of disease progression of MM after 1 or more prior lines of therapy with either of:
- Documented evidence of PD after achieving at least SD for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM)
- ≤ 25% response (i.e, patient never achieved ≥ MR) or PD during or within 60 days from end of the most recent MM regimen (i.e., refractory MM)
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- Patients must have measurable disease as defined by at least one of the following:
- Serum M-protein ≥ 0.5 g/dL by serum protein electrophoresis (SPEP) or, for IgA myeloma, by quantitative IgA c) Urinary M-protein excretion at least 200 mg/24 hours d) Serum FLC ≥ 10 mg/dL, provided that FLC ratio is abnormal e) If no measurable disease by serum or urine, then the presence of a plasmacytoma of ≥ 2cm in one dimension prior to start of study can be used to follow response via radiologic imaging
- Adequate hepatic function:
- 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 g) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN.
- Adequate renal function as determined by serum creatinine of ≤ 2 mg/dL OR estimated creatinine clearance of ≥ 20 mL/min, calculated using the Cockcroft and Gault formula (140 - Age) • Mass (kg)/ (72 • creatinine mg/dL); multiply by 0.85 if female.
- Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count ≥1000/mm3, hemoglobin ≥8 g/dL and 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).
- Patients may receive hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (eg, eltrombopag, romiplostim, or interleukin-11) at any time
- Patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of protocol required therapies.
Who cannot join
- Has received selinexor or another XPO1 inhibitor in a previous line of therapy
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Pregnant or breastfeeding females.
- Major surgery within 4 weeks prior to C1D1.
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- Active, unstable cardiovascular function, as indicated by the presence of:
- Symptomatic ischemia, or
- Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular 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), or
- Congestive heart failure of New York Heart Association Class ≥3 or known left ventricular ejection fraction <40%, or
- Myocardial infarction within 3 months prior to C1D1.
- Subjects with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/ml prior to first dose of trial treatment. Subjects with untreated hepatitis C virus (HCV) are allowed.
- Subjects 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 are allowed.
- Any 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, including prior gastric bypass or bowel resection procedures.
- Inability or unwillingness 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).
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Patients unwilling or unable to comply with the protocol, including providing 24-hour urine samples for urine protein electrophoresis at the required time points.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of three treatment selection groups. The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
Selection groups are as follows:
Group 1: Selinexor + pomalidomide + dexamethasone (SPd) Group 2: Selinexor + daratumumab + dexamethasone (SDd) Group 3: Selinexor + carfilzomib + dexamethasone (SKd)
Read the detailed description
This study is a single institution, open-label phase II study to evaluate the overall response rate achieved with selinexor and dexamethasone based three drug combination therapy, selected by physician's choice, in patients with relapsed/refractory multiple myeloma.
Patients with RRMM will be eligible for enrollment. During screening, in addition to standard of care disease assessments, participant's bone marrow aspirate will be evaluated using a novel ex vivo Myeloma Drug Sensitivity Testing platform (My-DST). The following agents will be eligible for physician's choice, and in parallel evaluated for sample sensitivity in MyDST: pomalidomide, carfilzomib and daratumumab. Agents will be tested individually, in combination with selinexor and in combination with selinexor and dexamethasone. Results from MyDST will be not be available to investigators at time of treatment assignment, but will be evaluated to better characterize test performance and relationship with treatment outcomes.
Investigators will assign patients to one of the following treatment combinations: Selinexor/Pomalidomide/Dexamethsone (SPd), Selinexor/Daratumumab/Dexamethasone (SDd) or Selinexor/Carfilzomib/Dexamethasone (SKd). Investigators will use patient specific considerations such as prior therapeutic exposures, response to / tolerance of prior therapies and comorbid conditions which may increase risk for toxicity with specific agents to guide expert judgement in selecting partner agent for selinexor and dexamethasone. Treatment will continue until progression of disease, unacceptable toxicity or death.
This study will evaluate if physician's choice partner drug selection for selinexor based combination therapy in RRMM will lead to an overall response rate of 75% or higher.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- Selinexor, Pomalidomide, Daratumumab, Carfilzomib, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Selinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1).
PomalidomideDrug
Oral Table
DaratumumabDrug
Injection
CarfilzomibDrug
Injection
DexamethasoneDrug
Oral tablet or injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment Options:
Selinexor 60 mg PO days 1, 8, 15 Pomalidomide 4 mg PO on days 1-21 Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 28 day treatment cycles
Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles >6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle
Selinexor 80 mg PO days 1, 8, 15 Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15.
Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 28 day treatment cycle Receives: Drug: Selinexor; Drug: Pomalidomide; Drug: Daratumumab; Drug: Carfilzomib; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
Measured: Overall response rate was assessed from C1D1 through 30 days post last dose (approximately 10 months).
Secondary outcomes (6)
MRD Negative Response Rate
To evaluate the minimal residual disease negative response rate achieved with physician's choice selinexor-based combination therapy assessed via NGS or multiparametric flow cytometry with sensitivity of 10-5.
Measured: 2 years following End of Treatment or date of progression (whichever comes first), assessed up to 2 years
Progression Free Survival
To evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy
Measured: From End of Treatment visit +2 years, or date of progression (whichever comes first), assessed up to 2 years
Overall Survival
To evaluate the overall survival achieved with physician's choice selinexor-based combination therapy after 2 years off of study treatment.
Measured: From study start date to study end date or death (whichever comes first), assessed up to 2 years
Duration of Response
To evaluate the duration of response achieved with physician's choice selinexor-based combination therapy
Measured: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
Time to Next Treatment
To evaluate the time to next treatment achieved with physician's choice selinexor-based combination therapy
Measured: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
Safety and Tolerability of Selinexor in Combination With Partner Backbone Agents
Occurrence, nature, and severity of adverse events
Measured: From first dose of study drug through 30 days after last dose of protocol required therapies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start18 Nov 2021
- Primary completion6 Aug 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Daniel Sherbenou, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925193
- Sponsor's protocol ID
- 20-2202.cc
- Other IDs
- P30CA046934
- Status last verified
- Sep 2026
- First submitted
- 19 May 2021
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04925193
- Acronym / sponsor ID
- 20-2202.cc
- Conditions
- Multiple Myeloma in Relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Karyopharm Therapeutics Inc, National Cancer Institute (NCI)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Posted 6 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Selinexor (KPT-330, Xpovio) is a first in class selective inhibitor of nuclear export which has been approved for use in relapsed and refractory multiple myeloma (RRMM). This trial will seek to evaluate the outcomes achieved with selinexor based combination in RRMM selected by physician's choice and compared prospectively to ex vivo drug sensitivity testing results. Participants will be enrolled and assigned into one of three treatment selection groups. The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
Selection groups are as follows:
Group 1: Selinexor + pomalidomide + dexamethasone (SPd) Group 2: Selinexor + daratumumab + dexamethasone (SDd) Group 3: Selinexor + carfilzomib + dexamethasone (SKd)
Detailed description
This study is a single institution, open-label phase II study to evaluate the overall response rate achieved with selinexor and dexamethasone based three drug combination therapy, selected by physician's choice, in patients with relapsed/refractory multiple myeloma.
Patients with RRMM will be eligible for enrollment. During screening, in addition to standard of care disease assessments, participant's bone marrow aspirate will be evaluated using a novel ex vivo Myeloma Drug Sensitivity Testing platform (My-DST). The following agents will be eligible for physician's choice, and in parallel evaluated for sample sensitivity in MyDST: pomalidomide, carfilzomib and daratumumab. Agents will be tested individually, in combination with selinexor and in combination with selinexor and dexamethasone. Results from MyDST will be not be available to investigators at time of treatment assignment, but will be evaluated to better characterize test performance and relationship with treatment outcomes.
Investigators will assign patients to one of the following treatment combinations: Selinexor/Pomalidomide/Dexamethsone (SPd), Selinexor/Daratumumab/Dexamethasone (SDd) or Selinexor/Carfilzomib/Dexamethasone (SKd). Investigators will use patient specific considerations such as prior therapeutic exposures, response to / tolerance of prior therapies and comorbid conditions which may increase risk for toxicity with specific agents to guide expert judgement in selecting partner agent for selinexor and dexamethasone. Treatment will continue until progression of disease, unacceptable toxicity or death.
This study will evaluate if physician's choice partner drug selection for selinexor based combination therapy in RRMM will lead to an overall response rate of 75% or higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Selinexor, Drug: Pomalidomide, Drug: Daratumumab, Drug: Carfilzomib, Drug: DexamethasoneTreatment Options: Selinexor 60 mg PO days 1, 8, 15 Pomalidomide 4 mg PO on days 1-21 Dexamethasone 40 mg PO or IV on days 1, 8, 15, 22 28 day treatment cycles Selinexor 80 mg PO days 1, 8, 15 Daratumumab 1,800mg/30,000 units subcutaneous injection on days 1, 8, 15, 22 of cycles 1 and 2, days 1, 15 of cycles 3-6, day 1 of cycles >6 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 28 day treatment cycle Selinexor 80 mg PO days 1, 8, 15 Carfilzomib IV infusion 20 mg/m2 cycle 1, day 1, 56 mg/m2 cycle 1 day 8, 15. Cycle 2+ days 1, 8, 15. Dexamethasone 40 mg IV or PO days 1, 8, 15, 22 28 day treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- 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
- Histologically confirmed diagnosis, measurable disease and evidence of disease progression of MM after 1 or more prior lines of therapy with either of:
- Patients must have measurable disease as defined by at least one of the following:
Key exclusion criteria (18 listed)
- Has received selinexor or another XPO1 inhibitor in a previous line of therapy
- Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Pregnant or breastfeeding females.
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 |
|---|---|---|
| SelinexorSelinexor is an oral, first-in-class, slowly reversible, potent selective inhibitor of nuclear export (SINE) compound that specifically blocks exportin 1 (XPO1). | Drug | Arm 1 |
| PomalidomideOral Table | Drug | Arm 1 |
| DaratumumabInjection | Drug | Arm 1 |
| CarfilzomibInjection | Drug | Arm 1 |
| DexamethasoneOral tablet or injection | Drug | Arm 1 |
Primary outcome
Overall Response Rate
Time frame: Overall response rate was assessed from C1D1 through 30 days post last dose (approximately 10 months).
To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
6 secondary outcomes
MRD Negative Response Rate
Time frame: 2 years following End of Treatment or date of progression (whichever comes first), assessed up to 2 years
Progression Free Survival
Time frame: From End of Treatment visit +2 years, or date of progression (whichever comes first), assessed up to 2 years
Overall Survival
Time frame: From study start date to study end date or death (whichever comes first), assessed up to 2 years
Duration of Response
Time frame: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
Time to Next Treatment
Time frame: End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
Safety and Tolerability of Selinexor in Combination With Partner Backbone Agents
Time frame: From first dose of study drug through 30 days after last dose of protocol required therapies
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Daniel Sherbenou, MD principal investigator
University of Colorado, Denver
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, Pomalidomide and Daratumumab in people with Multiple Myeloma in Relapse, run by University of Colorado, Denver 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 15 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: under way, not looking for participants, as of the sponsor's last update on 2 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 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?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Overall response rate was assessed from C1D1 through 30 days post last dose (approximately 10 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 2 Oct 2026.