Relapsed and Refractory Multiple MyelomaPhase 2SELVEDgeNCT05530421

Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Selinexor, Venetoclax and Dexamethasone in people with Relapsed and Refractory Multiple Myeloma, run by University of Miami at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed and Refractory Multiple Myeloma
What is being tested?: Selinexor, Venetoclax and Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 3 sitesUnited States
Study dates: 26 Mar 2023to 26 Mar 2030
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

Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG).5 Patients at initial diagnosis must have had a serum M-protein ≥ 3 g/dL and/or bone marrow plasma cells ≥10%, and at least one of the following:
Anemia: Hemoglobin ≤10 g/dL, or
Renal failure: serum creatinine ≥ 2.0 mg/dL, or
Hypercalcemia: Ca ≥10.5 mg/dL, or
Lytic bone lesions on X-ray, CT, or Positron emission tomography/Computed Tomography (PET/CT), or
≥ 2 focal lesions on spinal magnetic resonance imaging (MRI), or

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≥ 60% bone marrow plasma cells, or Involved/un-involved serum free light chain ratio ≥ 100. Age ≥18 years of age on day of signing informed consent.
Patients must have had a bone marrow (BM) biopsy proven plasma cell myeloma harboring the t(11;14) translocation as reported by a Clinical Laboratory Improvement Amendments (CLIA) certified assay (i.e. local fluorescence in situ hybridization (FISH) testing). BM biopsy can be performed at time of enrollment or documented FISH results (i.e. original FISH report) can be used.
Must have Relapsed or Relapsed and Refractory Multiple Myeloma. Patients must have documented evidence of having received two prior lines of therapy and be refractory to, not a candidate for (ineligible), or intolerant of at least one immunomodulatory (IMiD), one proteasome inhibitor, and one anti-cluster of differentiation 38 (anti-CD38) monoclonal antibody-based treatments.
Documented measurable disease based on the IMWG guidelines within the 4 weeks prior to registration defined by any one of the following criteria:
Serum monoclonal protein ≥ 0.5 g/dl
Urine monoclonal protein >200 mg/24 hour
Serum immunoglobulin free light chain >10 mg/dL AND abnormal kappa/lambda ratio
Bone marrow plasma cells ≥ 30%
A measurable lesion on PET/CT or MRI ≥ 2 cm
Be ≥ 18 years of age on day of signing informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 3 (Appendix A)
Adequate organ function as evidenced by the following laboratory parameters within 4 weeks of C1D1:
Hematologic:
Absolute neutrophil count (ANC) 1000/microliter (mcL) (granulocyte-colony stimulating factor (G-CSF) allowed)
Platelets ≥ 50,000/mcL (transfusions and stimulators permitted); in patients with >50% bone marrow plasma cells, platelets ≥ 30,000/mcL
Hemoglobin ≥ 8 g/dL (transfusions permitted)
Non-hematologic:
Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or calculated creatinine clearance (CrCl)/Estimated glomerular filtration rate (eGFR) (by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), Modification of Diet in Renal Disease (MDRD), or Cockcroft-Gault) ≥ 15 mL/min/1.73 m2
Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 X ULN)
Aspartate transaminase (SGOT) and alanine transaminase (SGPT) ≤ 2.5 X ULN
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 90 days following the last dose of study treatment.
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.

Who cannot join

Has received selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously.
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.
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.

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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 cluster of differentiation 4-positive (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.
Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (https://www.nccn.org/guidelines/category_3) 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 or known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alanna Vossen contact

305-243-7701

avossen@miami.edu

Dickran Kazandjian, MD contact

dkazandjian@miami.edu

United States3 sites, 3 recruiting

University of Miami, Lennar Foundation Medical Center
Coral Gables, Florida, 33146
Alanna Vossen, 305-243-7701, avossen@miami.edu
Dickran Kazandjian, MD, 718-795-6027, dkazandjian@miami.edu
Recruiting
University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Alanna Vossen, 305-243-7701, avossen@miami.edu
Dickran Kazandjian, MD, 718-795-6027, dkazandjian@miami.edu
Recruiting
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Alanna Vossen, 305-243-7701, avossen@miami.edu
Dickran Kazandjian, MD, dkazandjian@miami.edu
Recruiting

Other trials in United States

About this study

Official title: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (SELVEDge Study)

Conditions: Relapsed and Refractory Multiple Myeloma
Being tested: Selinexor, Venetoclax, Dexamethasone
Medical subject headings: Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelinexorDrug
Also called Xpovio
Selinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
VenetoclaxDrug
Also called Venclexta, Venclyxto
Venetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.
DexamethasoneDrug
Also called Decadron, Ozurdex, Dexycu
Dexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.

Study groups in NCT05530421
Study group	Role	What they receive
XVenD Group	Experimental	Participants will receive XVenD combination therapy of Selinexor (X), Venetoclax (Ven) and Dexamethasone (D) orally during each 28-day cycle. Doses will be administered as follows: * Cycle 1 Days 1 to 7: * Venetoclax 400 mg orally (PO), Days 1-7 * Dexamethasone 40 mg PO, Day 1 * Cycle 1 Days 8 to 28: * Venetoclax 800 mg PO, Days 8-28 * Dexamethasone 40 mg PO, Days 8, 15, and 22 * Cycles 2 to 4: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 40 mg PO, Days 1, 8, 15, and 22 * Cycle 5 and beyond: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 20 mg PO, Days 1, 8, 15, and 22 Selinexor dose will be reduced to 60 mg for remaining participants if after the first 6 participants complete the first cycle and 2 or more out of these first 6 participants experience dose-limiting toxicities (DLTs). Receives: Drug: Selinexor; Drug: Venetoclax; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Fraction of Participants Achieving Overall Response
Overall response rate (ORR) will be reported as the fraction of participants achieving either complete response (CR) or partial response (ORR = CR + PR) to study treatment. Response to therapy will be assessed by treating physician using International Myeloma Working Group 2016 response criteria.
Measured: Up to 3 years

Secondary outcomes (5)

Duration of Response (DoR)
Duration of response is defined as the elapsed time from date of partial response (PR) or better to the date of progressive disease (PD) or death, whichever is first.
Measured: Up to 3 years
Minimal Residual Disease Negative Complete Response Rate
Minimum residual disease negative (MRD negative) complete response (CR) rate will be reported as the fraction of participants achieving CR who show less than one myeloma cell per million bone marrow cells after protocol therapy. Response to therapy will be assessed using International Myeloma Working Group 2016 response criteria.
Measured: Up to 3 years
Progression-Free Survival (PFS)
Progression-free survival (PFS) will be defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving participants without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.
Measured: Up to 3 years
Overall Survival (OS)
Overall survival (OS) will be defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.
Measured: Up to 3 years
Rate of Treatment-Emergent Adverse Events
Safety and tolerability of assigned protocol treatment will be reported as the rate of treatment-related toxicity, including serious adverse events (SAEs), grade 3 or higher adverse events, and all-grade adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, as assessed by treating physician.
Measured: Up to 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 202326 Mar 2030

First posted7 Sep 2022
Study start26 Mar 2023
Primary completion26 Mar 2028 (estimated)
Study completion26 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relapsed and Refractory Multiple MyelomaStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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: 33 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05530421
Sponsor's protocol ID: 20220595
Acronym: SELVEDge
Status last verified: Feb 2026
First submitted: 2 Sep 2022
Last updated: 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (SELVEDge Study)
ClinicalTrials.gov ID: NCT05530421
Acronym / sponsor ID: SELVEDge / 20220595
Conditions: Relapsed and Refractory Multiple Myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 33 participants (estimated)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: Karyopharm Therapeutics Inc
Study start: 26 Mar 2023 (actual)
Primary completion: 26 Mar 2028 (estimated)
Study completion: 26 Mar 2030 (estimated)
First posted: 7 Sep 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
XVenD Group	Experimental	Drug: Selinexor, Drug: Venetoclax, Drug: DexamethasoneParticipants will receive XVenD combination therapy of Selinexor (X), Venetoclax (Ven) and Dexamethasone (D) orally during each 28-day cycle. Doses will be administered as follows: * Cycle 1 Days 1 to 7: * Venetoclax 400 mg orally (PO), Days 1-7 * Dexamethasone 40 mg PO, Day 1 * Cycle 1 Days 8 to 28: * Venetoclax 800 mg PO, Days 8-28 * Dexamethasone 40 mg PO, Days 8, 15, and 22 * Cycles 2 to 4: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 40 mg PO, Days 1, 8, 15, and 22 * Cycle 5 and beyond: * Selinexor 80 mg PO, Days 1, 8, 15, and 22 * Venetoclax 800 mg PO, Days 1-28 * Dexamethasone 20 mg PO, Days 1, 8, 15, and 22 Selinexor dose will be reduced to 60 mg for remaining participants if after the first 6 participants complete the first cycle and 2 or more out of these first 6 participants experience dose-limiting toxicities (DLTs).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG).5 Patients at initial diagnosis must have had a serum M-protein ≥ 3 g/dL and/or bone marrow plasma cells ≥10%, and at least one of the following:
Patients must have had a bone marrow (BM) biopsy proven plasma cell myeloma harboring the t(11;14) translocation as reported by a Clinical Laboratory Improvement Amendments (CLIA) certified assay (i.e. local fluorescence in situ hybridization (FISH) testing). BM biopsy can be performed at time of enrollment or documented FISH results (i.e. original FISH report) can be used.
Must have Relapsed or Relapsed and Refractory Multiple Myeloma. Patients must have documented evidence of having received two prior lines of therapy and be refractory to, not a candidate for (ineligible), or intolerant of at least one immunomodulatory (IMiD), one proteasome inhibitor, and one anti-cluster of differentiation 38 (anti-CD38) monoclonal antibody-based treatments.
Documented measurable disease based on the IMWG guidelines within the 4 weeks prior to registration defined by any one of the following criteria:
Be ≥ 18 years of age on day of signing informed consent

Key exclusion criteria (12 listed)

Has received selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously.
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
SelinexorAlso: XpovioSelinexor tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.	Drug	XVenD Group
VenetoclaxAlso: Venclexta, VenclyxtoVenetoclax tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.	Drug	XVenD Group
DexamethasoneAlso: Decadron, Ozurdex, DexycuDexamethasone tablets will be administered orally (PO) once per day at assigned dosage and frequency per protocol.	Drug	XVenD Group

Primary outcome

Fraction of Participants Achieving Overall Response
Time frame: Up to 3 years
Overall response rate (ORR) will be reported as the fraction of participants achieving either complete response (CR) or partial response (ORR = CR + PR) to study treatment. Response to therapy will be assessed by treating physician using International Myeloma Working Group 2016 response criteria.

5 secondary outcomes

Duration of Response (DoR)
Time frame: Up to 3 years
Minimal Residual Disease Negative Complete Response Rate
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Rate of Treatment-Emergent Adverse Events
Time frame: Up to 10 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 23 Feb 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.

Alanna Vossen contact

305-243-7701

avossen@miami.edu

Dickran Kazandjian, MD contact

dkazandjian@miami.edu

Dickran Kazandjian, MD principal investigator

University of Miami

3 sites 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, Venetoclax and Dexamethasone in people with Relapsed and Refractory Multiple Myeloma, run by University of Miami at 3 sites 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 28 inclusion and 12 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Alanna Vossen (305-243-7701, avossen@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fraction of Participants Achieving Overall Response (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05530421.

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 23 Feb 2026.