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

Last updated: January 30, 2026
Sponsor: Karyopharm Therapeutics Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Multiple Myeloma

Cancer

Leukemia

Treatment

Dexamethasone

Pomalidomide

Bortezomib

Clinical Study ID

NCT04414475
XPORT-MM-028
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 institutionalguidelines.

  • 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 proteinelectrophoresis (SPEP) or, for Immunoglobulin (Ig) A myeloma, by quantitativeIgA.

  2. Urinary M-protein excretion >= 200 mg/24 hours.

  3. Free light chain (FLC) >= 100 milligram per liter (mg/L), provided that the FLCratio 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 havepreviously received at least 4 anti-MM prior therapies and have MM that isrefractory to previous treatment with at least 2 proteasome inhibitors (PIs), atleast 2 immunomodulatory agent (IMiDs), and 1 anti-cluster of differentiation (CD38)monoclonal antibody. Refractory is defined as lesser than or equal to (<=) 25percent (%) 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 andhave been previously treated with >=3 anti-MM therapies (with exposure to at least 2PI drugs, at least 2 IMiDs, and 1 anti-CD38 monoclonal antibody), and be refractoryto 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 daysafter completion of therapy.

  • Only for arm SVd: Participants must have previously received 1 to 5 anti-MM priortherapies 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 ofcontraception and have a negative serum pregnancy test at screening, and maleparticipants must use an effective barrier method of contraception if sexuallyactive with a female of childbearing potential. For both male and femaleparticipants, effective methods of contraception must be used throughout the studyand for 7 months for female and 4 months for male following the discontinuation ofstudy treatment.

Exclusion

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 >= 2peripheral neuropathy with pain at baseline, regardless of whether or not theparticipant is currently receiving medication.

  • Radiation, chemotherapy, immunotherapy, or any other anticancer therapy (includinginvestigational therapies) <= 2 weeks prior to Cycle 1 Day 1 (C1D1). (Steroids arepermitted 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 treatmentsthat 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 andGault.

  • 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, orantifungals 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 thestudy treatment.

  • Known active hepatitis A, B, or C infection; or known to be positive for hepatitis Cvirus RNA or hepatitis B virus surface antigen.

  • Female participants who are pregnant or lactating.

  • Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapyat C1D1.

  • Concurrent therapy with approved or investigational anticancer therapeutic includingtopical therapies.

  • Prior exposure to a SINE compound, including selinexor.

  • Serious, active psychiatric or active medical conditions which, in the opinion ofthe Investigator or the Sponsor, could interfere with the participation in thestudy.

  • Contraindication to any of the required concomitant drugs or supportive treatments.

Study Design

Total Participants: 127
Treatment Group(s): 4
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
July 01, 2020
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • University General Hospital of Patras

    Patra, Achaia 2654
    Greece

    Site Not Available

  • University General Hospital of Patras

    Pátrai 255683, Achaia 2654
    Greece

    Completed

  • General Hospital of Athens "ALEXANDRA"

    Attiki, Athens 11528
    Greece

    Site Not Available

  • General Hospital of Athens "Alexandra"

    Attiki 264354, Athens 11528
    Greece

    Active - Recruiting

  • General Hospital of Athens "Alexandra"

    Athens 264371, Attica 6692632 115 28
    Greece

    Active - Recruiting

  • General Hospital of Athens "Evaggelismos"

    Athens 264371, Attica 6692632 10676
    Greece

    Active - Recruiting

  • General Hospital of Athens "Evangelismos"

    Athens 264371, Attica 6692632 10676
    Greece

    Active - Recruiting

  • General Hospital of Athens "Evaggelismos"

    Athens, Attiki 10676
    Greece

    Site Not Available

  • Theageneion Cancer Hospital

    Thessaloniki 734077, Thessaloniki 54007
    Greece

    Active - Recruiting

  • Theageneion Cancer Hospital

    Thessaloniki, 54007
    Greece

    Site Not Available

  • Emek Medical Center

    Afula 295740, Afula 1834111
    Israel

    Active - Recruiting

  • Assuta Ashdod Medical Center

    Ashdod 295629, Ashdod 7747629
    Israel

    Active - Recruiting

  • Bnai-Zion Medical Center

    Haifa 294801, Haifa District 294800 3108
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa 294801, Haifa District 294800 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem 281184, Jerusalem 293198 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem 281184, Jerusalem 293198 9103102
    Israel

    Active - Recruiting

  • Rabin Medical Center (Beilinson Hospital)

    Petah Tikva 293918, Petah Tikva 49100
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center at Tel HaShomer

    Ramat Gan 293788, Ramat Gan 52621
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, Tel Aviv 293396 64239
    Israel

    Active - Recruiting

  • Emek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Assuta Ashdod Medical Center

    Ashdod, 7747629
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Barzilai Medical Center

    Ashkelon 295620, 7830604
    Israel

    Active - Recruiting

  • Soroka University Medical Center

    Beer-Sheva,
    Israel

    Site Not Available

  • Soroka University Medical Center

    Beersheba 295530,
    Israel

    Site Not Available

  • Bnai-Zion Medical Center

    Haifa, 3108
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba 294514, 4428164
    Israel

    Completed

  • Rabin Medical Center (Beilinson Hospital)

    Petah Tikva, 49100
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center at Tel HaShomer

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

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