18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SVd/Vd Arm: Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)Primary· From date of randomization until IRC-confirmed documented PD or death, censored date, whichever occurred first (up to 33 months)
PFS was defined as time from date of randomization until the first date of IRC-confirmed PD, per International Myeloma Working Group (IMWG) response criteria, or death due to any cause, whichever occurs first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absolute increase must be \>= 200 mg per 24 hours); d) in participants without measurable serum and urine
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
13.93
11.73 – NA
Vd Arm: Bortezomib + Dexamethasone
9.46
8.11 – 10.78
SVd/Vd Arm: Overall Response Rate (ORR) as Assessed by IRCSecondary· From date of randomization until disease progression or initiating a new MM treatment (up to 33 months)
ORR was defined as the percentage of the participants who achieved any confirmed partial response (PR) or better PR, complete response (CR), very good partial response (VGPR) or stringent complete response (sCR) based on the IRC's response outcome assessments, according to the International Myeloma Working Group (IMWG) response criteria, before IRC-confirmed PD or initiating a new MM treatment. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on elect
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
76.4
69.8 – 82.2
Vd Arm: Bortezomib + Dexamethasone
62.3
55.3 – 68.9
SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC AssessmentSecondary· From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)
Response rate was defined as percentage of participants with responses of VGPR, at any time prior to IRC-confirmed PD or initiating a new MM treatment. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
44.6
37.5 – 51.9
Vd Arm: Bortezomib + Dexamethasone
32.4
26.0 – 39.2
SVd/Vd Arm: Number of Participants With at Least One Grade Greater Than or Equal to [>=] 2 Peripheral Neuropathy EventsSecondary· From first dose of study treatment to 30 days after the last dose of study treatment inclusive, or the day before the start of new anti-MM treatment, whichever occurs first (up to 33 months)
Peripheral neuropathy events was assessed using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. The grade ranges from Grade 1 (mild, asymptomatic, or mild symptoms) to Grade 5 (death related to an adverse event). Grade 2 indicates a moderate condition that may require minimal intervention and can limit certain daily activities. Grade 3 represents severe symptoms that are not immediately life-threatening but may lead to hospitalization and restrict self-care activities. Grade 4 denotes life-threatening consequences requiring urgent interven
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
41
Vd Arm: Bortezomib + Dexamethasone
70
SVd/Vd Arm: Overall Survival (OS)Secondary· From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)
OS was defined as the time from the date of randomization until either the date of death due to any cause or until the participant is lost to follow-up, for all participants.
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
36.67
30.19 – NA
Vd Arm: Bortezomib + Dexamethasone
32.76
27.83 – NA
SVd/Vd Arm: Duration of Response (DOR) as Assessed by IRCSecondary· From the first documentation of response to the first documentation of PD or death, whichever occurred first (up to 45 months)
DOR was defined as the duration of time from the first occurrence of an IRC confirmed response of at least (\>=) PR until the first date of IRC-confirmed PD or death due to any cause, whichever occurred first. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; PD: Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>= 5 g/dL; Urine M-protein (absolute increase
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
17.28
12.55 – 26.25
Vd Arm: Bortezomib + Dexamethasone
12.88
9.26 – 15.77
SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX TreatmentSecondary· From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)
ORR was defined as the percentage of the participants who achieved a confirmed partial response or better (i.e., PR, VGPR, CR, or sCR) based on the IRC's response outcome assessments, according to the IMWG response criteria. PR: \>=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>=90% or \<200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hours; CR: Negative immunofixation on the serum and urine and disappearance of
Group
Value
95% CI
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
19.0
10.2 – 30.9
SVdX Arm: Progression Free Survival1 (PFS1) as Assessed by IRC During SVdX TreatmentSecondary· From date of first SVdX treatment until IRC-confirmed documented PD or death or censored date, whichever occurred first (up to 33 months)
PFS1 is defined as the duration of time from the date of the first dose of the SVd treatment after crossover from the Vd arm until the first date of PD or death due to any cause, whichever occurred first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absolute increase must be \>= 200 mg per 24 hours); d) in participants without measurable serum and urine M-pr
Group
Value
95% CI
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
3.91
3.48 – 6.93
SVd/Vd Arm: Time-to-next-treatment (TTNT) in Participants Randomized to the SVd and Vd Arm Who Received Treatment After SVd/VdSecondary· From date of randomization to start of next anti-MM treatment or death, whichever occurred first (up to 33 months)
TTNT is defined as the duration from date of randomization to start of next anti-MM treatment or death, whichever occurs first. For patients without an event, their follow-up time will be censored at the date of discontinuation from study, or last participating visit on or before database cutoff date, whichever occurs first.
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
16.13
13.93 – NA
Vd Arm: Bortezomib + Dexamethasone
10.84
9.82 – 13.40
SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd ArmSecondary· From randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR), whichever occurred first (up to 33 months)
TTR was defined as duration from randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR) before IRC-confirmed PD or initiating a new MM treatment per IMWG response criteria. The participants who do not achieve IRC-confirmed PR or better response will be censored at the date of last disease assessment on or before database cutoff date. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or great
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
1.41
1.35 – 1.51
Vd Arm: Bortezomib + Dexamethasone
1.61
1.51 – 2.14
SVd/Vd/SVdx Arm: Progression Free Survival 2 (PFS 2) in Participants Randomized to the SVd and Vd Arm Who Received Post-SVd/Vd/SVdX TreatmentSecondary· From date of first dose of post-SVd/Vd/SVdX treatment to the date of first PD on post-SVd/Vd/SVdX treatment, or death due to any cause (up to 33 months)
PFS 2 was defined as the duration of time from the date of the first dose of the treatment after SVd/Vd/SVdX until the first date of PD on treatment after SVd/Vd/SVdX or death due to any cause, whichever occurred first. PD included increase of 25% from lowest confirmed response value in 1 or more of the following criteria: a) serum M-protein with absolute increase of \>= 0.5 gram per deciliter (g/dL); b) serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; c) urine M-protein (absolute increase must be \>= 200 mg per 24 hours); d) in participants without measurable serum
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
6.60
5.39 – 9.43
Vd Arm (Non-Crossover): Bortezomib + Dexamethasone
8.84
5.78 – NA
SVdX Arm: Selinexor + Bortezomib + Dexamethasone
3.88
2.79 – NA
SVd/Vd Arm: Change From Baseline in Participant-Reported Peripheral Neuropathy (PN) Assessed by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire- Chemotherapy-Induced PN 20 (EORTC- QLQ-CIPN20) Total ScoresSecondary· Svd Arm: Baseline up to End of treatment (EOT) (at Day 820); Vd Arm: Baseline up to EOT (at Day 848)
The EORTC QLQ-CIPN20 instrument is a 20-item QoL instrument, which has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN. The QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) containing a 4-point Likert scale (1= not at all, 2= a little, 3= quite a bit, and 4= very much), participants indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and
Total Sensory Score: Change at EOT
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
3.38
± 12.436
Vd Arm: Bortezomib + Dexamethasone
11.17
± 19.069
Total Motor Score: Change at EOT
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
3.56
± 14.513
Vd Arm: Bortezomib + Dexamethasone
9.02
± 18.662
Total Autonomic Score: Change at EOT
Group
Value
95% CI
SVd Arm: Selinexor + Bortezomib + Dexamethasone
10.41
± 22.201
Vd Arm: Bortezomib + Dexamethasone
10.92
± 25.306
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of randomization up to 45 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07447817 — Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
· Phase 2
· not yet recruiting
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07204041 — Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory
· Phase 2
· active not recruiting
NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se
· Phase 1, PHASE2
· recruiting
NCT06900088 — Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients
· Phase 2
· not yet recruiting
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
· Phase 1
· recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
· Phase 1
· recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma
· Phase 2
· recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma
· Phase 2
· recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With
· Phase 3
· recruiting
Other Karyopharm Therapeutics Inc trials
Trials by the same sponsor.
NCT04854434 — A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previo
· Phase 2
· terminated
NCT04768881 — Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
· Phase 2
· terminated
NCT04421378 — A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
· Phase 1, PHASE2
· terminated
NCT04355676 — Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COV
· Phase 2
· withdrawn
NCT04349098 — Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Karyopharm Therapeutics Inc
Last refreshed: 21 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03110562.