NCT04414475RecruitingPhase 2
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 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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (estimated)
- First submitted
- 2 Jun 2020
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Karyopharm Therapeutics Inc
- Diseases
- Multiple myeloma
- NCT number
- NCT04414475
- EU CT number
- 2024-511608-18-00
- EudraCT number
- 2020-000821-22
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 127
- From 1 Jul 2020 to the primary completion date, 31 Jan 2028
- 15 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Ongoing clinically significant non-hematological toxicities from prior treatments that are Grade greater than (\>) 2 at C1D1.
- Major surgery within 4 weeks prior to C1D1.
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose.
- Concurrent therapy with approved or investigational anticancer therapeutic including topical therapies.
- Prior exposure to a SINE compound, including selinexor.
- Contraindication to any of the required concomitant drugs or supportive treatments.
Other illness
- Active graft vs. host disease (after allogeneic stem cell transplantation) at C1D1.
- Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus RNA or hepatitis B virus surface antigen.
- Known intolerance, hypersensitivity, or contraindication to glucocorticoid therapy at C1D1.
- 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.
Lab values
- 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
Other
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active central nervous system MM.
- Life expectancy of \< 4 months, based on the opinion of the Investigator.
- Active gastrointestinal dysfunction interfering with the ability to swallow tablets, or any gastrointestinal dysfunction that could interfere with absorption of the study treatment.
- Female participants who are pregnant or lactating.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Evangelismos S A Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Emek Medical Center Coordinator of this site? Confirm its status | Afula | Israel | Active, not recruiting |
| Assuta Ashdod Medical Center Coordinator of this site? Confirm its status | Ashdod | Israel | Active, not recruiting |
| Barzilai Medical Center Coordinator of this site? Confirm its status | Ashkelon | Israel | Recruiting |
| Soroka University Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Completed |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Bnai Zion Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Completed |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Active, not recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Completed |
| Rabin Medical Center- Beilinson Hospital Coordinator of this site? Confirm its status | Petah Tikva | Israel | Completed |
| The Chaim Sheba Medical Center at Tel HaShomer Coordinator of this site? Confirm its status | Ramat Gan | Israel | Completed |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.