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RecruitingNCT04414475Updated Oct 1, 2026

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

A Phase 2 interventional study of Selinexor and Dexamethasone in Multiple Myeloma, Refractory, sponsored by Karyopharm Therapeutics Inc. Recruiting at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Karyopharm Therapeutics Inc · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Updated Oct 1, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Myeloma, Refractory

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Keywords

  • Multiple Myeloma
  • Selinexor
  • Penta-refractory Multiple Myeloma
  • Triple-class Refractory Multiple Myeloma
  • KPT-330
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 127 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Karyopharm Therapeutics Inc is the lead sponsor of 36 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (estimated)

Study arms

  • 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 · Drug: Dexamethasone

  • 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 · Drug: Dexamethasone

  • 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 · Drug: Dexamethasone

  • 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 · Drug: Dexamethasone · Drug: Bortezomib

Interventions

  • DrugSelinexor

    Participants will receive Selinexor oral tablets.

    Also known as: KPT-330, XPOVIO

  • DrugDexamethasone

    Participants will receive Dexamethasone oral tablets.

    Also known as: Decadron

  • DrugBortezomib

    Participants will receive Bortezomib SC injection.

    Also known as: Velcade

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: From the date of randomization up to death (approximately 60 months)

Secondary outcomes

  1. Duration of Response (DOR)

    Time frame: From the date of randomization to first disease progression or death (approximately 60 months)

  2. Clinical Benefit Rate (CBR)

    Time frame: From the date of randomization up to death (approximately 60 months)

  3. Disease control rate (DCR)

    Time frame: From the date of randomization up to death (approximately 60 months)

  4. Progression-Free Survival (PFS)

    Time frame: From the date of randomization to first disease progression or death (approximately 60 months)

  5. Overall Survival (OS)

    Time frame: From the date of randomization up to death (approximately 60 months)

  6. Time to Next Treatment (TTNT)

    Time frame: From the date of first dose up to death (approximately 60 months)

  7. Number of Participants with Adverse Events (AE)

    Time frame: From start of study drug administration up to follow-up (approximately 60 months)

07

Study locations

7 of 16 sites recruiting
  • University General Hospital of Patras
    Pátrai, Achaia 2654, Greece
    Completed
  • General Hospital of Athens "Alexandra"
    Attiki, Athens 11528, Greece
    • Prof. Maria Gavriatopoulou · Contact · mariagabria@gmail.com · +30 693 413 7080
    • Prof. Maria Gavriatopoulou · Principal investigator
    Recruiting
  • General Hospital of Athens "Evangelismos"
    Athens, Attica 10676, Greece
    • Dr. Sosana Delimpasi · Contact · sodeli@yahoo.com · +30 697 720 4193
    • Dr. Sosana Delimpasi · Principal investigator
    Recruiting
  • Theageneion Cancer Hospital
    Thessaloniki, Thessaloniki 54007, Greece
    Recruiting
  • Emek Medical Center
    Afula, Afula 1834111, Israel
    Active, not recruiting
  • Assuta Ashdod Medical Center
    Ashdod, Ashdod 7747629, Israel
    Recruiting
  • Bnai-Zion Medical Center
    Haifa, Haifa District 3108, Israel
    Completed
  • Rambam Health Care Campus
    Haifa, Haifa District 3109601, Israel
    Recruiting
  • Shaare Zedek Medical Center
    Jerusalem, Jerusalem 9103102, Israel
    Active, not recruiting
  • Hadassah Medical Center
    Jerusalem, Jerusalem 9112001, Israel
    Recruiting
  • Rabin Medical Center (Beilinson Hospital)
    Petah Tikva, Petah Tikva 49100, Israel
    Completed
  • The Chaim Sheba Medical Center at Tel HaShomer
    Ramat Gan, Ramat Gan 52621, Israel
    Completed
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Tel Aviv 64239, Israel
    Completed
  • Barzilai Medical Center
    Ashkelon, 7830604, Israel
    • Anatoly Nemets, MD · Contact
    • · Contact · anatolyn@bmc.gov.il · 972 8 6745796
    • Anatoly Nemets, MD · Principal investigator
    Recruiting
  • Soroka University Medical Center
    Beersheba, Israel
    Completed
  • Meir Medical Center
    Kfar Saba, 4428164, Israel
    Completed
08

References and documents

Publications

  • White D, Schiller GJ, Madan S, Lentzsch S, Chubar E, Lavi N, Van Domelen DR, Bentur OS, Baljevic M. Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Front Oncol. 2024 May 17;14:1352281. doi: 10.3389/fonc.2024.1352281. eCollection 2024. PubMed 38826786 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Sites
7 sites changed recruiting status
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    7 sites changed recruiting status
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04414475
Lead sponsor
Karyopharm Therapeutics Inc
Responsible party
Sponsor
First posted
Jun 4, 2020
Start date
Jul 1, 2020
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Karyopharm Medical Information
Contact
clinicaltrials@karyopharm.com
(888) 209-9326

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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