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Multiple MyelomaPhase 2SABLeNCT04717700

Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients

A Phase 2 study testing Selinexor 20 MG Oral Tablet, Bortezomib Injection and Lenalidomide capsule in people with Multiple Myeloma, run by Ida Bruun Kristensen at 11 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Selinexor 20 MG Oral Tablet, Bortezomib Injection and Lenalidomide capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
11 sitesin 3 countries
Study dates
18 Aug 2021to 1 Jun 2029
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

  • Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
  • Age > 18 years
  • Willing and able to provide written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2. ECOG 3 allowed if caused by myeloma
  • Newly diagnosed multiple myeloma with treatment demanding disease as defined by IMWG (Rajkumar, Dimopoulos et al. 2014) and measurable disease as defined IMWG 2016 criteria (Table 5) (Kumar, Paiva et al. 2016)
  • By treating physician considered in-eligible for high-dose therapy with stem-cell transplant
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  • Patients must have received no prior chemotherapy for multiple myeloma. Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis). Patients must have received no prior steroid treatment for myeloma with the exception of a maximum of 14 days of treatment for symptom control (including dexamethasone 40mg).
  • Adequate hepatic function within 7 days prior to C1D1:
  • Total bilirubin < 1.5 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 × ULN), and
  • Alanine aminotransferase (ALT) normal to <2 × ULN.
  • Adequate renal function within 7 days prior to C1D1 as determined by estimated GFR of ≥ 30 mL/min, calculated using standard formula.
  • Adequate hematopoietic function within 7 days prior to C1D1: Absolute neutrophil count ≥1000/mm3, and platelet count ≥100,000/mm3 (patients for whom <50% of bone marrow nucleated cells are plasma cells). If cytopenias are due a plasma cell infiltration in the bone marrow (biopsy-proven heavy-marrow involvement, as defined by having at least 30% marrow cellularity, with > 50% of the cells being malignant plasma cells (documented marrow results required)); in this case, although there are no required lower limits of normal for the blood counts, the treating physician must use his/her medical judgment as to the appropriateness of this study therapy for these patients.
  • Erythropoietin-analogues are allowed.
  • Patients must have:
  • At least a 1-week interval from the last platelet transfusion prior to the screening platelet assessment.
  • However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study.
  • Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
  • Patients must be able to take prophylactic anticoagulation as recommended by study
  • Patients with pathologic fractures, infection at diagnosis or symptomatic hyperviscosity must have these conditions attended to prior to registration (i.e., intramedullary rod, I.V. antibiotics, plasmapheresis)

Who cannot join

  • Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
  • Has received selinexor or another XPO1 inhibitor previously.
  • Has any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.
  • Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide and selinexor.
  • Pregnant or breastfeeding females.
  • Life expectancy of less than 6 months.
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  • Active, unstable cardiovascular function, as indicated by the presence of:
  • Symptomatic ischemia, or
  • Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or
  • Congestive heart failure of New York Heart Association Class ≥3 or known left ventricular ejection fraction <40%, or
  • Myocardial infarction within 6 months prior to C1D1.
  • Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment.
  • Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO) (NCCN CPGO) for antiemesis and anorexia/cachexia (palliative care).
  • Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
  • Contraindication to any of the required concomitant drugs or supportive treatments.
  • Patients unwilling or unable to comply with the protocol

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Norway6 sites

  • Haukeland University Hospital

    Bergen

  • Førde Central Hospital

    Førde

  • Kristiansund Hospital

    Kristiansund

  • Oslo Universitets Hospital

    Oslo

  • Stavanger University Hospital

    Stavanger

  • St. Olavs University Hospital

    Trondheim

Other trials in Norway

Denmark4 sites

  • Aalborg University Hospital

    Aalborg

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg

  • Regionshospitalet Gødstrup

    Gødstrup

  • Odense University Hospital

    Odense

Other trials in Denmark

Estonia1 site

  • North Estonia Medical Centre Foundation

    Tallinn, Tallinn, 13419

Other trials in Estonia

About this study

Official title: Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients (SABLe): An Investigator Sponsored Trial

An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group

Read the detailed description

An unrandomized phase 2 study evaluating selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up with in the Nordic Multiple Myeloma Study Group.

The study will include 50 patients, recruited within the NMSG collaborating countries. After induction patient will be treated with continued lenalidomide-dexamethasone according to SWOG, with continuous 40mg selinexor weekly in the selinexor arm (experimental arm B).

Being tested
Selinexor 20 MG Oral Tablet, Bortezomib Injection, Lenalidomide capsule, Dexamethasone Oral
Keywords
selinexor
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Selinexor 20 MG Oral TabletDrug

    Also called Xpovio

    Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

  • Bortezomib InjectionDrug

    Also called Velcade

    Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

  • Lenalidomide capsuleDrug

    Also called Revlimid

    Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

  • Dexamethasone OralDrug

    Also called Neofordex

    Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

Study groups in NCT04717700
Study groupRoleWhat they receive
B -selinexor-lenalidomide/bortezomib-dexamethasoneExperimentalAlternating cycles of: Selinexor oral 40mg once weekly Lenalidomide oral 25mg d 1-21 Dexamethasone 20mg d 1+2, 8+9 and 15+16 i 28 days cycles and Selinexor oral 80mg once weekly Bortezomib sc 1.3mg/sqm once weekly Dexamethasone 20mg d 1+2, 8+9 and 15+16 in 28 days cycles for up to 16 cycles (8 of each, alternating) followed by continuos selinexor 40mg(once weekly)-lenalidomide-dexamethasone for up to 16 cycles followed by continuos lenalidomide-dexamethasone
Receives: Drug: Selinexor 20 MG Oral Tablet; Drug: Bortezomib Injection; Drug: Lenalidomide capsule; Drug: Dexamethasone Oral

What is being measured

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

  1. Increased ORR in arm B (defined as ≥PR) at end of induction, defined according to IMWG response criteria

    ORR at end of induction, with response defined according to IMWG response criteria

    Measured: Estimated at 4-8 weeks after end of induction

Secondary outcomes (5)

  1. Increased VGPR rate at end of induction in arm B

    VGPR rate at end of induction

    Measured: Estimated at 4-8 weeks after end of induction

  2. Increased rate of MRD negativity at end of induction in arm B

    MRD negativity by NGS at end of induction

    Measured: Estimated at 4-8 weeks after end of induction

  3. Decreased time to response in arm B

    Time to at least PR from start of treatment

    Measured: Estimated monthly during the first 64 weeks

  4. Evaluate toxicity rates between arm A and B, including rates of secondary primary malignancies

    Comparison of toxicity rates according to NCI-CTCAE v4.03

    Measured: Estimated at 4-8 weeks after end of induction

  5. Decreased time to at least VGPR

    Time to at least VGPR from start of treatment

    Measured: Estimated monthly during the first 64 weeks

Timeline

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

  1. First posted22 Jan 2021
  2. Study start18 Aug 2021
  3. Primary completion1 Dec 2025
  4. Study completion1 Jun 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04717700
Sponsor's protocol ID
NMSG 29/21
Acronym
SABLe
Status last verified
Oct 2026
First submitted
18 Jan 2021
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor 20 MG Oral Tablet, Bortezomib Injection and Lenalidomide capsule in people with Multiple Myeloma, run by Ida Bruun Kristensen at 11 sites in 3 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 19 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 16 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 11 sites in Norway, Denmark, Estonia. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased ORR in arm B (defined as ≥PR) at end of induction, defined according to IMWG response criteria (time frame: Estimated at 4-8 weeks after end of induction). 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 NCT04717700.

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 16 Oct 2026.

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