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Multiple MyelomaPhase 3NCT05028348

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

A Phase 3 study testing Selinexor, Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 20 sites in 4 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD)… 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, Elotuzumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
20 sitesin 4 countries
Study dates
19 Apr 2022to Mar 2029
Phase
Phase 3
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

  • Relapsed or refractory MM with measurable disease per IMWG guidelines as defined by at least 1 of the following:
  • Serum M-protein ≥0.5 g/dL (≥5 g/L) by serum protein electrophoresis (SPEP) or, for immunoglobulin (Ig) A or D myeloma, by quantitative serum IgA or IgD levels ≥ 0.5 g/dL.
  • Urinary M-protein excretion ≥200 mg/24 hours
  • Serum free light chain (FLC) ≥100 mg/L, provided that the FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65)
  • Received at least 1 and no more than 4 prior anti-MM lines of therapy. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy.
  • Prior therapy that includes ≥ consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination
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  • Prior therapy with an anti-CD38 mAb as part of their immedicate last treatment prior to study entry (Before protocol version2.0, patient with any prior therapy with an anti-CD38 mAb were eligible for the study).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to Grade ≤1 by Cycle 1 Day 1 (C1D1). Patients with Grade 2 non-hematological toxicities may be included.
  • Adequate hepatic function within 28 days prior to C1D1:
  • Total bilirubin <2 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of <3 × ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × ULN
  • Adequate renal function within 28 days prior to C1D1 (estimated creatinine clearance [CrCl] of ≥15 mL/min (not requiring dialysis), calculated using the formula of Cockcroft and Gault or measured by 24-hour urine collection).
  • Adequate hematopoietic function within 7 days prior to C1D1 defined as absolute neutrophil count ≥1.5 x 109/L , hemoglobin ≥8.5 g/dL, and platelet count ≥100 x 109/L (patients for whom <50% of bone marrow nucleated cells are plasma cells) or ≥75 x 109/L (patients for whom ≥50% of bone marrow nucleated cells are plasma cells).
  • Patients receiving hematopoietic growth factor support, including erythropoietin, darbepoetin, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), and platelet stimulators (e.g., eltrombopag, romiplostim, or interleukin-11) must have a 2-week interval between growth factor support and the Screening assessments, but they may receive growth factor support during the study.
  • Patients must have:
  • At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the Screening hemoglobin assessment, and
  • 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.
  • Patients with active hepatitis B virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/mL. Patients with evidence of non-active HBV should be discussed with the Medical Monitor and should be monitored or receive prophylaxis at the discretion of the Investigator and study site institutional guidelines
  • Patients with a history of hepatitis C virus (HCV) are eligible if they have received adequate curative anti-HCV treatment and HCV viral load is below the limit of quantification.
  • Patients with a history of human immunodeficiency virus (HIV) are eligible if they have CD4+ T cell counts ≥350 cells/µL, negative viral load, and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year and should be on established antiretroviral therapy (ART) for at least 4 weeks.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 10 to 14 days and a second test within 24 hours prior to the first dose of study treatment. Female patients of childbearing potential and fertile male patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
  • Age ≥18 years at the time of signing informed consent.
  • Written informed consent signed in accordance with federal, local, and institutional guidelines.
  • Patients must be able and willing to take enteric-coated aspirin according to clinical practice, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (international normalized ratio [INR] 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE) at the Investigator's discretion. For patient on warfarin, INR should be repeated as clinically indicated. Use of alternative anticoagulants, such as direct oral anticoagulants, may be considered per Investigator discretion.

Who cannot join

  • Smoldering MM.
  • Plasma cell leukemia.
  • Documented active systemic amyloid light chain amyloidosis.
  • Any history of central nervous system MM.
  • Prior treatment with:
  • A selective inhibitor of nuclear export (SINE) compound, including selinexor
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  • Pomalidomide and/or elotuzumab.
  • Any concurrent medical condition or disease that is likely to interfere with study procedures.
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1. Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
  • Known intolerance, hypersensitivity, or contraindication to any of the study treatments.
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy including investigational therapies and high dose dexamethasone (i.e., 40 mg daily for 4 days per week) ≤2 weeks prior to C1D1. Patients on long-term glucocorticoids during Screening do not require a washout period but must be able to tolerate the specified dexamethasone dose in this study.
  • Prior autologous stem cell transplantation <60 days or allogeneic stem cell transplantation <4 months prior to C1D1.
  • Major surgery within 4 weeks prior to C1D1.
  • Active graft versus host disease after allogeneic stem cell transplantation.
  • Pregnant or breastfeeding females.
  • In the opinion of the Investigator, patients who are below their ideal body weight and would be unduly impacted by changes in their weight.
  • Clinically significant cardiac disease, including:
  • Myocardial infarction within 6 months before C1D1, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV).
  • Uncontrolled cardiac arrhythmia (CTCAE v. 5.0 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
  • Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec.
  • 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.
  • 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

20 sites in 4 countries.

20 sites in 4 countries

Spain12 sites

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Institut Catala D Oncolocia Hospitalet - Hospital Duran i Reynals

    Barcelona

  • Hospital de Cabueñes

    Gijón

  • Institut Català D'Oncologia - Hospital Dr. Josep Trueta

    Girona

  • Hospital Universitario 12 de Octubre

    Madrid

  • H. General Universitario Morales Meseguer

    Murcia

  • Clínica Universidad de Navarra (CUN)

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca

  • H. Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela

  • H.U. La Fe

    Valencia

Other trials in Spain

Germany4 sites

  • Klinikum Chemnitz

    Chemnitz

  • Marien Hospital Dusseldorf

    Düsseldorf

  • University Medicine Greifswald, Medical Clinic and Polyclinic for Internal Medicine

    Greifswald

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg

Other trials in Germany

France3 sites

  • CHRU Hôtel Dieu

    Nantes

  • CHU Hôpital Saint Antoine

    Paris

  • La Pitié

    Paris

Other trials in France

Greece1 site

  • Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

    Athens

Other trials in Greece

About this study

Official title: A Phase 3 Randomized, Open-label Trial of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

Being tested
Selinexor, Elotuzumab, Pomalidomide, Dexamethasone Oral
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

    Selinexor will be given as an oral dose 40 mg (2 20 mg tablets) QW on Days 1, 8, 15, and 22 of each 28-day cycle.

  • ElotuzumabDrug

    Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.

  • PomalidomideDrug

    Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.

  • Dexamethasone OralDrug

    Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Preferred dosing of dexamethasone is 40 mg QW for patients who are ≤75 years of age (20 mg QW for >75-year-old patients at the Investigator's discretion) before QW dosing of selinexor, however, it may be divided over 2 days at the Investigator's discretion.

Study groups in NCT05028348
Study groupRoleWhat they receive
Selinexor, pomalidomide and dexamethasone (SPd)ExperimentalSelinexor will be given as an oral dose: 40 mg (2 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. * Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle. * Patients ≤75 years: o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion. * Patients > 75 years: * Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Receives: Drug: Selinexor; Drug: Pomalidomide; Drug: Dexamethasone Oral
Elotuzumab, Pomalidomide and Dexamethasone (EloPd)Active comparatorElotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle. * Pomalidomide will be given as an oral 4 mg dose once a day (QD) on Days 1 to 21 of each 28-day cycle. * Patients ≤75 years: * Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing * Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion. * Patients >75 years: * Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing * Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Receives: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone Oral

What is being measured

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

  1. Progression-free survival (PFS)

    from date of randomization until the date of first confirmed progressive disease (PD), per IMWG response criteria, or death due to any cause, whichever occurs first.

    Measured: from randomization to the date of disease progression or death (approximately up to 5 years)

Secondary outcomes (9)

  1. Overall Response Rate (ORR)

    defined as any response ≥PR (i.e., PR [partial response], VGPR [very good partial response], CR ([complete response], or sCR [stringent complete response])

    Measured: from screening until end of treatment/progressive disease (approximately up to 2 years)

  2. Overall survival (OS)

    Overall Survival

    Measured: From randomization until death from any cause (up to 3 years after end of treatment)

  3. Duration of response

    Duration of response (PR or better), duration of CR, duration of sCR, and duration of minimal residual disease (MRD) -negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, whichever occurs first.

    Measured: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment, and every 3 months up to 3 years

  4. Time to response

    Time to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR)

    Measured: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment, and every 3 months up to 3 years

  5. Progression-free survival on the next line of therapy (PFS2)

    Progression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.

    Measured: the time from randomization to progression on the next line of treatment or death, whichever comes first., assessed up to approx. 5 years

  6. Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms

    The EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.

    Measured: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (up to 2 years)

  7. Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score and the difference between-treatment arms

    The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.

    Measured: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)

  8. EQ-5D-5L health utility values and the difference between-treatment arms

    The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"

    Measured: screening, Day 1 of each treatment cycle (each cycle is 28 days), at end of treatment (approximately up to 2 years)

  9. safety and tolerability of SPd versus EloPd in patients with RRMM

    Safety and tolerability of study treatment will be evaluated based on occurrence, nature and severity of adverse events as categorized by the Common Terminology Criteria of Adverse Events (CTCAE) v5.0

    Measured: continuously from screening untill 30 days after last study treatment. (approximately up to 2 years)

Timeline

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

  1. First posted31 Aug 2021
  2. Study start19 Apr 2022
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028348
Sponsor's protocol ID
EMN29
Status last verified
Sep 2025
First submitted
25 Aug 2021
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selinexor, Elotuzumab and Pomalidomide in people with Multiple Myeloma, run by European Myeloma Network B.V. at 20 sites in 4 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 26 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain, Germany, France, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-free survival (PFS) (time frame: from randomization to the date of disease progression or death (approximately up to 5 years)). 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 NCT05028348.

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 4 Dec 2025.

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Clinical Trial NCT05028348 | AzTrials