Actively Recruiting
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Led by Karyopharm Therapeutics Inc · Updated on 2026-02-02
127
Participants Needed
16
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 multiple myeloma based on IMWG guidelines defined by at least one: serum M-protein >= 0.5 g/dL by serum protein electrophoresis or quantitative IgA for IgA myeloma, urinary M-protein excretion >= 200 mg/24 hours, or free light chain >= 100 mg/L with abnormal ratio.
- For specified study arms prior to protocol version 5.0: relapsed or refractory multiple myeloma with at least 4 prior anti-MM therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and 1 anti-CD38 monoclonal antibody.
- For specified study arms as of protocol version 5.0: relapsed or refractory multiple myeloma with at least 3 prior anti-MM therapies, exposure to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and 1 anti-CD38 monoclonal antibody, refractory to at least one drug of each class.
- For the SVd arm: previously treated with 1 to 5 prior anti-MM therapies and refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, 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 contraception methods and have a negative pregnancy test at screening; males must use effective barrier contraception if sexually active with females of childbearing potential. Effective contraception must continue throughout the study and for 7 months (females) or 4 months (males) after treatment ends.
You will not qualify if you...
- Active plasma cell leukemia.
- Documented systemic amyloid light chain amyloidosis.
- Active central nervous system multiple myeloma.
- For SVd arm: peripheral neuropathy greater than Grade 2 or Grade >= 2 with pain at baseline.
- Radiation, chemotherapy, immunotherapy, or other anticancer therapy within 2 weeks before Cycle 1 Day 1, except steroids allowed up to 40 mg/day for 4 days in that period.
- Active graft versus host disease after allogeneic stem cell transplantation at Cycle 1 Day 1.
- Clinically significant non-hematological toxicities greater than Grade 2 at Cycle 1 Day 1.
- Inadequate liver function defined by specific elevated bilirubin, AST, and ALT levels.
- Inadequate kidney function with creatinine clearance less than 20 mL/min.
- Inadequate hematopoietic function with low neutrophil count, platelet count, or hemoglobin below specified thresholds.
- Life expectancy less than 4 months.
- Major surgery within 4 weeks before Cycle 1 Day 1.
- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week before first dose.
- Active gastrointestinal dysfunction affecting swallowing or absorption of study drugs.
- Known active hepatitis A, B, or C infection.
- Pregnancy or lactation.
- Known intolerance or contraindication to glucocorticoid therapy.
- Concurrent therapy with approved or investigational anticancer treatments.
- Prior exposure to selective inhibitor of nuclear export compounds including selinexor.
- Serious active psychiatric or medical conditions interfering with study participation.
- Contraindication to required concomitant drugs or supportive treatments.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
University General Hospital of Patras
Pátrai, Achaia, Greece, 2654
Completed
2
General Hospital of Athens "Alexandra"
Attiki, Athens, Greece, 11528
Actively Recruiting
3
General Hospital of Athens "Evangelismos"
Athens, Attica, Greece, 10676
Actively Recruiting
4
Theageneion Cancer Hospital
Thessaloniki, Thessaloniki, Greece, 54007
Actively Recruiting
5
Emek Medical Center
Afula, Afula, Israel, 1834111
Actively Recruiting
6
Assuta Ashdod Medical Center
Ashdod, Ashdod, Israel, 7747629
Actively Recruiting
7
Bnai-Zion Medical Center
Haifa, Haifa District, Israel, 3108
Actively Recruiting
8
Rambam Health Care Campus
Haifa, Haifa District, Israel, 3109601
Actively Recruiting
9
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel, 9103102
Actively Recruiting
10
Hadassah Medical Center
Jerusalem, Jerusalem, Israel, 9112001
Actively Recruiting
11
Rabin Medical Center (Beilinson Hospital)
Petah Tikva, Petah Tikva, Israel, 49100
Actively Recruiting
12
The Chaim Sheba Medical Center at Tel HaShomer
Ramat Gan, Ramat Gan, Israel, 52621
Actively Recruiting
13
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, Israel, 64239
Actively Recruiting
14
Barzilai Medical Center
Ashkelon, Israel, 7830604
Actively Recruiting
15
Soroka University Medical Center
Beersheba, Israel
Active, Not Recruiting
16
Meir Medical Center
Kfar Saba, Israel, 4428164
Completed
Research Team
K
Karyopharm Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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