Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma.
Darrell White, Gary J Schiller, Sumit Madan...
https://pubmed.ncbi.nlm.nih.gov/38826786Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04414475
A Phase 2b, Open-label, Multi-arm Clinical Trial of Selinexor Plus Low-dose Dexamethasone in Penta-refractory Multiple Myeloma or Selinexor and Bortezomib Plus Low-dose Dexamethasone in Triple-class Refractory Multiple Myeloma
Led by Karyopharm Therapeutics Inc · Updated on 2026-02-02
127
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness, cancer-fighting activity, safety, and tolerability of selinexor combined with low-dose dexamethasone in adults with penta-refractory multiple myeloma, as well as selinexor combined with bortezomib and low-dose dexamethasone in those with triple-class refractory multiple myeloma. The study is a Phase 2b, open-label, multi-arm clinical trial investigating these treatments in patients who have experienced resistance to multiple prior therapies. Participants are assigned to one of several treatment groups. One group receives a fixed dose of 40 mg selinexor tablets plus 20 mg dexamethasone tablets twice weekly on specific days during each 28-day cycle. Another group receives 100 mg selinexor and 40 mg dexamethasone once weekly, with dexamethasone dosing possibly split over two days. Some earlier treatment arms with different dosing schedules are closed to new participants. Another group receives selinexor tablets, subcutaneous bortezomib injections, and dexamethasone tablets on a 35-day cycle with flexible dexamethasone dosing. During the study, participants will be monitored for overall response rate up to about 60 months after randomization. Secondary outcomes include duration of response, clinical benefit, disease control, progression-free and overall survival, time to next treatment, and recording of adverse events. Assessments and safety monitoring occur throughout the study period to gather comprehensive data on treatment effects and tolerability.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at signing consent
- Written informed consent according to guidelines
- Measurable multiple myeloma based on serum or urine protein levels or free light chain abnormalities
- For Sd-40 BIW, Sd-100 QW, and Sd-80 BIW arms before protocol version 5.0: Relapsed or refractory MM with at least 4 prior anti-MM therapies and refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and 1 anti-CD38 antibody
- For Sd-40 BIW and Sd-100 QW arms as of protocol version 5.0: RR MM treated with 3 or more anti-MM therapies including exposure and refractory status to PI, IMiD, and anti-CD38 classes
- For SVd arm: Previous treatment with 1 to 5 anti-MM therapies and refractory to at least 1 PI, 1 IMiD, and 1 anti-CD38 antibody
- ECOG performance status of 2 or less
- Female participants of childbearing potential must use dual contraception methods and have negative pregnancy test; males must use effective barrier contraception throughout and after study
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
- Recent anticancer therapy within 2 weeks before study start (except limited steroid use)
- Active graft versus host disease at study start
- Significant non-hematological toxicities above Grade 2
- Liver function abnormalities beyond specified limits
- Kidney function less than 20 mL/min creatinine clearance
- Low blood counts below specified thresholds
- Life expectancy less than 4 months
- Major surgery within 4 weeks before study start
- Uncontrolled active infections within 1 week before first dose
- Gastrointestinal conditions interfering with swallowing or absorption
- Known active hepatitis A, B, or C infection
- Pregnancy or lactation
- Known intolerance or contraindication to glucocorticoids
- Concurrent approved or investigational anticancer therapies
- Prior exposure to SINE compounds including selinexor
- Serious psychiatric or medical conditions interfering with participation
- Contraindications to required supportive treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day or 35-day cycles until disease progression or discontinuation.
Participants receive oral Selinexor and low-dose Dexamethasone tablets, with some also receiving Bortezomib subcutaneous injections, according to their assigned treatment arm.
Weekly visits for up to approximately 60 months
Follow-up
Duration - Up to approximately 60 months
Participants are monitored for overall survival, disease progression, and adverse events after treatment ends.
Visits as scheduled during follow-up period
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
Loading map...
Research Team
K
Karyopharm Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here