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Multiple Myeloma, RefractoryPhase 2NCT04414475

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 study testing Selinexor, Dexamethasone and Bortezomib in people with Multiple Myeloma, Refractory, run by Karyopharm Therapeutics Inc at 16 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Refractory
What is being tested?
Selinexor, Dexamethasone and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
16 sitesin 2 countries
Study dates
1 Jul 2020to Jan 2028
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

  • 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:
  • Serum M-protein >= 0.5 gram per deciliter (g/dL) by serum protein electrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitative IgA.
  • Urinary M-protein excretion >= 200 mg/24 hours.
  • Free light chain (FLC) >= 100 milligram per liter (mg/L), provided that the FLC ratio is abnormal.
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  • 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.

Who cannot join

  • 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.
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  • 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:
  • Absolute neutrophil count (ANC) < 1000/cubic millimeter (mm^3)
  • Platelet count < 75,000/mm^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.

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Karyopharm Medical Information contact

(888) 209-9326

clinicaltrials@karyopharm.com

16 sites in 2 countries

Israel12 sites, 3 recruiting

  • Emek Medical Center

    Afula, Afula, 1834111

    Active, not recruiting

  • Assuta Ashdod Medical Center

    Ashdod, Ashdod, 7747629

    Active, not recruiting

  • Barzilai Medical Center

    Ashkelon, 7830604

    Anatoly Nemets, MD

    972 8 6745796, anatolyn@bmc.gov.il

    Recruiting

  • Soroka University Medical Center

    Beersheba

    Completed

  • Bnai-Zion Medical Center

    Haifa, Haifa District, 3108

    Completed

  • Rambam Health Care Campus

    Haifa, Haifa District, 3109601

    Noa Lavi, 972 50 206 1332, n_lavi@rambam.health.gov.il

    Noa Lavi

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

    Active, not recruiting

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

    Moshe Gatt, 972-505172333, rmoshg@hadassah.org.il

    Moshe Gatt

    Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164

    Completed

  • Rabin Medical Center (Beilinson Hospital)

    Petah Tikva, Petah Tikva, 49100

    Completed

  • The Chaim Sheba Medical Center at Tel HaShomer

    Ramat Gan, Ramat Gan, 52621

    Completed

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv, 64239

    Completed

Other trials in Israel

Greece4 sites, 3 recruiting

  • General Hospital of Athens "Evangelismos"

    Athens, Attica, 10676

    Dr. Sosana Delimpasi, +30 697 720 4193, sodeli@yahoo.com

    Dr. Sosana Delimpasi

    Recruiting

  • General Hospital of Athens "Alexandra"

    Attiki, Athens, 11528

    Prof. Maria Gavriatopoulou, +30 693 413 7080, mariagabria@gmail.com

    Prof. Maria Gavriatopoulou

    Recruiting

  • University General Hospital of Patras

    Pátrai, Achaia, 2654

    Completed

  • Theageneion Cancer Hospital

    Thessaloniki, Thessaloniki, 54007

    Eirini Katoudritou, +30 697 487 2869, eirinikatodritou@gmail.com

    Eirini Katoudritou

    Recruiting

Other trials in Greece

About this study

Official title: 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.

Being tested
Selinexor, Dexamethasone, Bortezomib
Keywords
Multiple Myeloma, Selinexor, Penta-refractory Multiple Myeloma, Triple-class Refractory Multiple Myeloma, KPT-330
Medical subject headings
Multiple Myeloma

What participants receive

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

  • SelinexorDrug

    Also called KPT-330, XPOVIO

    Participants will receive Selinexor oral tablets.

  • DexamethasoneDrug

    Also called Decadron

    Participants will receive Dexamethasone oral tablets.

  • BortezomibDrug

    Also called Velcade

    Participants will receive Bortezomib SC injection.

Study groups in NCT04414475
Study groupRoleWhat they receive
Selinexor + Low-dose Dexamethasone (Sd-40 BIW)ExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Dexamethasone
Selinexor + Low-dose Dexamethasone (Sd-100 QW)ExperimentalParticipants 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).
Receives: Drug: Selinexor; Drug: Dexamethasone
Selinexor + Low-dose Dexamethasone (Sd-80 BIW)ExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Dexamethasone
Selinexor + Bortezomib + Dexamethasone (SVd)ExperimentalParticipants 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.
Receives: Drug: Selinexor; Drug: Dexamethasone; Drug: Bortezomib

What is being measured

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

  1. Overall Response Rate (ORR)

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

Secondary outcomes (7)

  1. Duration of Response (DOR)

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

  2. Clinical Benefit Rate (CBR)

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

  3. Disease control rate (DCR)

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

  4. Progression-Free Survival (PFS)

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

  5. Overall Survival (OS)

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

  6. Time to Next Treatment (TTNT)

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

  7. Number of Participants with Adverse Events (AE)

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

Timeline

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

  1. First posted4 Jun 2020
  2. Study start1 Jul 2020
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414475
Sponsor's protocol ID
XPORT-MM-028
Status last verified
Oct 2026
First submitted
2 Jun 2020
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Dexamethasone and Bortezomib in people with Multiple Myeloma, Refractory, run by Karyopharm Therapeutics Inc at 16 sites in 2 countries.

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 11 inclusion and 24 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 29 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 16 sites in Israel, Greece. 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 Karyopharm Medical Information ((888) 209-9326, clinicaltrials@karyopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: From the date of randomization up to death (approximately 60 months)). 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 NCT04414475, which also lists 1 linked publication.

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 29 Oct 2026.

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