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
1 other identifier
interventional
127
2 countries
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
February 2, 2026
January 1, 2026
7.5 years
June 2, 2020
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
From the date of randomization up to death (approximately 60 months)
Secondary Outcomes (7)
Duration of Response (DOR)
From the date of randomization to first disease progression or death (approximately 60 months)
Clinical Benefit Rate (CBR)
From the date of randomization up to death (approximately 60 months)
Disease control rate (DCR)
From the date of randomization up to death (approximately 60 months)
Progression-Free Survival (PFS)
From the date of randomization to first disease progression or death (approximately 60 months)
Overall Survival (OS)
From the date of randomization up to death (approximately 60 months)
- +2 more secondary outcomes
Study Arms (4)
Selinexor + Low-dose Dexamethasone (Sd-40 BIW)
EXPERIMENTALParticipants will receive fixed dose of 40 milligram (mg) of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet twice weekly (BIW) on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle.
Selinexor + Low-dose Dexamethasone (Sd-100 QW)
EXPERIMENTALParticipants will receive fixed dose of 100 mg of Selinexor oral tablet followed by 40 mg of low-dose Dexamethasone oral tablet once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. (Dexamethasone may be given as 20 mg on days 1 and 2 of each week at the discretion of the treating physician).
Selinexor + Low-dose Dexamethasone (Sd-80 BIW)
EXPERIMENTALParticipants will receive fixed dose of 80 mg of Selinexor oral tablet followed by 20 mg of low-dose Dexamethasone oral tablet BIW on Days 1, 3, 8, 10,15, 17, 22, and 24 of each 28-day cycle. Closed for recruitment.
Selinexor + Bortezomib + Dexamethasone (SVd)
EXPERIMENTALParticipants will receive fixed dose of 100 mg of Selinexor oral tablet on Days 1, 8, 15, 22, and 29 followed by 1.3 milligram per square-meter (mg/m\^2) of Bortezomib subcutaneous (SC) injection on Days 1, 8, 15, and 22 and followed by 40 mg of low-dose Dexamethasone oral tablet on Days 1, 8, 15, 22, and 29 of each 35-day cycle (Dexamethasone dose may be split to 20 mg on days 1 and 2 of each week at the discretion of the treating physician). Closed for recruitment.
Interventions
Participants will receive Selinexor oral tablets.
Participants will receive Dexamethasone oral tablets.
Participants will receive Bortezomib SC injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- Absolute neutrophil count (ANC) \< 1000/cubic millimeter (mm\^3)
- Platelet count \< 75,000/mm\^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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University General Hospital of Patras
Pátrai, Achaia, 2654, Greece
General Hospital of Athens "Alexandra"
Attiki, Athens, 11528, Greece
General Hospital of Athens "Evangelismos"
Athens, Attica, 10676, Greece
Theageneion Cancer Hospital
Thessaloniki, Thessaloniki, 54007, Greece
Emek Medical Center
Afula, Afula, 1834111, Israel
Assuta Ashdod Medical Center
Ashdod, Ashdod, 7747629, Israel
Bnai-Zion Medical Center
Haifa, Haifa District, 3108, Israel
Rambam Health Care Campus
Haifa, Haifa District, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Rabin Medical Center (Beilinson Hospital)
Petah Tikva, Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center at Tel HaShomer
Ramat Gan, Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv, 64239, Israel
Barzilai Medical Center
Ashkelon, 7830604, Israel
Soroka University Medical Center
Beersheba, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Related Publications (1)
White D, Schiller GJ, Madan S, Lentzsch S, Chubar E, Lavi N, Van Domelen DR, Bentur OS, Baljevic M. Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Front Oncol. 2024 May 17;14:1352281. doi: 10.3389/fonc.2024.1352281. eCollection 2024.
PMID: 38826786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
June 4, 2020
Study Start
July 1, 2020
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
February 2, 2026
Record last verified: 2026-01