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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

127

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

July 1, 2020

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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