A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.

January 30, 2026 updated by: Karyopharm Therapeutics Inc

A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone (Sd) in Patients With Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone (SVd) in Patients With Triple-class Refractory Multiple Myeloma

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
    • Achaia
      • Pátrai, Achaia, Greece, 2654
        • Completed
        • University General Hospital of Patras
    • Athens
      • Attiki, Athens, Greece, 11528
        • Recruiting
        • General Hospital of Athens "Alexandra"
        • Principal Investigator:
          • Prof. Maria Gavriatopoulou
        • Contact:
    • Attica
      • Athens, Attica, Greece, 10676
        • Recruiting
        • General Hospital of Athens "Evangelismos"
        • Principal Investigator:
          • Dr. Sosana Delimpasi
        • Contact:
    • Thessaloniki
      • Thessaloniki, Thessaloniki, Greece, 54007
        • Recruiting
        • Theageneion Cancer Hospital
        • Principal Investigator:
          • Eirini Katoudritou
        • Contact:
  • Israel
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center
        • Contact:
          • Anatoly Nemets, MD
        • Contact:
        • Principal Investigator:
          • Anatoly Nemets, MD
      • Beersheba, Israel
        • Active, not recruiting
        • Soroka University Medical Center
      • Kfar Saba, Israel, 4428164
        • Completed
        • Meir Medical Center
    • Afula
      • Afula, Afula, Israel, 1834111
        • Recruiting
        • Emek Medical Center
        • Contact:
        • Principal Investigator:
          • Evgeni Chubar
    • Ashdod
      • Ashdod, Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center
        • Principal Investigator:
          • Merav Leiba
        • Contact:
    • Haifa District
      • Haifa, Haifa District, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
        • Contact:
        • Principal Investigator:
          • Noa Lavi
      • Haifa, Haifa District, Israel, 3108
        • Recruiting
        • Bnai-Zion Medical Center
        • Principal Investigator:
          • Tamar Tadmor
        • Contact:
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
        • Principal Investigator:
          • moshe gatt
      • Jerusalem, Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
        • Principal Investigator:
          • Chezi Ganzel
    • Petah Tikva
      • Petah Tikva, Petah Tikva, Israel, 49100
        • Recruiting
        • Rabin Medical Center (Beilinson Hospital)
        • Contact:
        • Principal Investigator:
          • Amos Cohen
    • Ramat Gan
      • Ramat Gan, Ramat Gan, Israel, 52621
        • Recruiting
        • The Chaim Sheba Medical Center at Tel HaShomer
        • Contact:
        • Principal Investigator:
          • Hila Magen
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Yael Cohen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age greater than or equal to (>=)18 years at the time of signing informed consent.
  • Written informed consent in accordance with federal, local, and institutional guidelines.

  • Measurable MM based on IMWG guidelines as defined by at least one of the following:

    1. Serum M-protein >= 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.
    2. Urinary M-protein excretion >= 200 mg/24 hours.
    3. Free light chain (FLC) >= 100 milligram per liter (mg/L), provided that the FLC ratio is abnormal.
  • Only for arms Sd-40 BIW, Sd-100 QW and Sd-80 BIW prior to protocol version (PV) 5.0: Participants must have relapsed or refractory multiple myeloma (RRMM) and have previously received at least 4 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 2 proteasome inhibitors (PIs), at least 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38) monoclonal antibody. Refractory is defined as lesser than or equal to (<=) 25 percent (%) response to therapy, or progression during therapy or progression within 60 days after completion of therapy.
  • Only for Arms Sd-40 BIW and Sd-100 QW as of PV 5.0: Participants must have RR MM and have been previously treated with >=3 anti-MM therapies (with exposure to at least 2 PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractory to at least 1 drug of each class (PI/IMiD/anti-CD38). Refractory is defined as <=25% response to therapy or progression during therapy or progression within 60 days after completion of therapy.
  • Only for arm SVd: Participants must have previously received 1 to 5 anti-MM prior therapies and have MM that is refractory to previous treatment with at least 1 PI, at least 1 IMiD, and 1 anti- CD38 monoclonal antibody.
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Female participants of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 7 months for female and 4 months for male following the discontinuation of study treatment.

Exclusion Criteria:

  • Active plasma cell leukemia.
  • Documented systemic amyloid light chain amyloidosis.
  • Active central nervous system MM.
  • Only for SVd arm: Greater than Grade 2 peripheral neuropathy or Grade >= 2 peripheral neuropathy with pain at baseline, regardless of whether or not the participant is currently receiving medication.
  • Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (including investigational therapies) <= 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids are permitted up to 1 pulse of 40 mg per day for 4 days in the 2 weeks prior to C1D1).
  • Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
  • Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade greater than (>) 2 at C1D1.
  • Inadequate hepatic function defined as total bilirubin >= 2x upper limit of normal (ULN) (>= 3x ULN for participants with Gilbert's syndrome), aspartate transaminase (AST) >= 2.5x ULN, and alanine transaminase (ALT) >= 2.5x ULN.
  • Inadequate renal function defined as estimated creatinine clearance of lesser than (<) 20 milliliter per minute (mL/min), calculated using the formula of Cockroft and Gault.

  • Inadequate hematopoietic function defined as the following:

    1. Absolute neutrophil count (ANC) < 1000/cubic millimeter (mm^3)
    2. Platelet count < 75,000/mm^3
    3. Hemoglobin (Hb) level < 8.5 g/dL
  • Life expectancy of < 4 months, based on the opinion of the Investigator.
  • Major surgery within 4 weeks prior to C1D1.
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.
  • Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.
  • Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus RNA or hepatitis B virus surface antigen.
  • Female participants who are pregnant or lactating.
  • Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at C1D1.
  • Concurrent therapy with approved or investigational anticancer therapeutic including topical therapies.
  • Prior exposure to a SINE compound, including selinexor.
  • Serious, active psychiatric or active medical conditions which, in the opinion of the Investigator or the Sponsor, could interfere with the participation in the study.
  • Contraindication to any of the required concomitant drugs or supportive treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
Participants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.
Drug: Selinexor
Participants will receive Selinexor oral tablets.
Other Names:
  • KPT-330
  • XPOVIO
Drug: Dexamethasone
Participants will receive Dexamethasone oral tablets.
Other Names:
  • Decadron
Experimental: Selinexor + Low-dose Dexamethasone (Sd-100 QW)
Participants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week at the discretion of the treating physician).
Drug: Selinexor
Participants will receive Selinexor oral tablets.
Other Names:
  • KPT-330
  • XPOVIO
Drug: Dexamethasone
Participants will receive Dexamethasone oral tablets.
Other Names:
  • Decadron
Experimental: Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
Participants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle. Closed for recruitment.
Drug: Selinexor
Participants will receive Selinexor oral tablets.
Other Names:
  • KPT-330
  • XPOVIO
Drug: Dexamethasone
Participants will receive Dexamethasone oral tablets.
Other Names:
  • Decadron
Experimental: Selinexor + Bortezomib + Dexamethasone (SVd)
Participants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2 of each week at the discretion of the treating physician). Closed for recruitment.
Drug: Selinexor
Participants will receive Selinexor oral tablets.
Other Names:
  • KPT-330
  • XPOVIO
Drug: Dexamethasone
Participants will receive Dexamethasone oral tablets.
Other Names:
  • Decadron
Drug: Bortezomib
Participants will receive Bortezomib SC injection.
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: From the date of randomization up to death (approximately 60 months)
From the date of randomization up to death (approximately 60 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: From the date of randomization to first disease progression or death (approximately 60 months)
From the date of randomization to first disease progression or death (approximately 60 months)
Clinical Benefit Rate (CBR)
Time Frame: From the date of randomization up to death (approximately 60 months)
From the date of randomization up to death (approximately 60 months)
Disease control rate (DCR)
Time Frame: From the date of randomization up to death (approximately 60 months)
From the date of randomization up to death (approximately 60 months)
Progression-Free Survival (PFS)
Time Frame: From the date of randomization to first disease progression or death (approximately 60 months)
From the date of randomization to first disease progression or death (approximately 60 months)
Overall Survival (OS)
Time Frame: From the date of randomization up to death (approximately 60 months)
From the date of randomization up to death (approximately 60 months)
Time to Next Treatment (TTNT)
Time Frame: From the date of first dose up to death (approximately 60 months)
From the date of first dose up to death (approximately 60 months)
Number of Participants with Adverse Events (AE)
Time Frame: From start of study drug administration up to follow-up (approximately 60 months)
From start of study drug administration up to follow-up (approximately 60 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karyopharm Therapeutics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XPORT-MM-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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