New hope for patients with advanced multiple myeloma: drug combo shows promise
NCT ID NCT04414475
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called selinexor combined with a low-dose steroid (dexamethasone) in people with multiple myeloma that has stopped responding to many other treatments. Some participants will also receive another drug, bortezomib. The goal is to see if these combinations can shrink tumors and control the disease. About 127 adults aged 18 and older with specific types of refractory myeloma will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 127 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Assuta Ashdod Medical Center
RECRUITINGAshdod, Ashdod, 7747629, Israel
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Barzilai Medical Center
RECRUITINGAshkelon, 7830604, Israel
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Bnai-Zion Medical Center
RECRUITINGHaifa, Haifa District, 3108, Israel
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Emek Medical Center
RECRUITINGAfula, Afula, 1834111, Israel
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General Hospital of Athens "Alexandra"
RECRUITINGAttiki, Athens, 11528, Greece
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General Hospital of Athens "Evangelismos"
RECRUITINGAthens, Attica, 10676, Greece
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Hadassah Medical Center
RECRUITINGJerusalem, Jerusalem, 9112001, Israel
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Meir Medical Center
COMPLETEDKfar Saba, 4428164, Israel
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Rabin Medical Center (Beilinson Hospital)
RECRUITINGPetah Tikva, Petah Tikva, 49100, Israel
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Rambam Health Care Campus
RECRUITINGHaifa, Haifa District, 3109601, Israel
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Shaare Zedek Medical Center
RECRUITINGJerusalem, Jerusalem, 9103102, Israel
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Soroka University Medical Center
ACTIVE_NOT_RECRUITINGBeersheba, Israel
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Tel Aviv Sourasky Medical Center
RECRUITINGTel Aviv, Tel Aviv, 64239, Israel
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The Chaim Sheba Medical Center at Tel HaShomer
RECRUITINGRamat Gan, Ramat Gan, 52621, Israel
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Theageneion Cancer Hospital
RECRUITINGThessaloniki, Thessaloniki, 54007, Greece
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University General Hospital of Patras
COMPLETEDPátrai, Achaia, 2654, Greece
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