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NCT05597345
Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma
Phase 2 trial testing Selinexor in Smoldering Multiple Myeloma in 15 participants. Currently enrolling.
29 October 2024
Quick facts
| Lead sponsor | University of Rochester |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 21 August 2023 |
| Primary completion | 29 October 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Selinexor — full drug profile →
Conditions studied
- Smoldering Multiple Myeloma — all drugs for Smoldering Multiple Myeloma →
Sponsor
University of Rochester
Who can join
18 and older, any sex, with Smoldering Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multiple myeloma: clinical characteristics, current therapies and emerging innovative treatments targeting ribosome biogenesis dynamics.
Elbahoty MH, Papineni B, Samant RS. · · 2024 · cited 10× · PMID 39162964 · DOI 10.1007/s10585-024-10305-2 -
Novel-and Not So Novel-Inhibitors of the Multifunctional CRM1 Protein.
Aumann WK, Kazi R, Harrington AM, Wechsler DS. · · 2024 · cited 3× · PMID 39161560 · DOI 10.3389/or.2024.1427497 -
Smoldering multiple myeloma: Integrating biology and risk into management.
Patel R, Hill E, Dhodapkar M. · · 2025 · cited 2× · PMID 39603907 · DOI 10.1053/j.seminhematol.2024.10.002 -
Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?
Sokolova V, Gruber R, Pammer LM, Kocher F, et al · · 2024 · cited 1× · PMID 39729162 · DOI 10.1007/s11033-024-10169-5 -
Navigating the evolving management of smoldering multiple myeloma.
Hammami MB, Canevarolo RR, Silva AS, Alsina M, et al · · 2026 · PMID 41523082 · DOI 10.1002/hem3.70275
Verify or expand the search:
- PubMed search for NCT05597345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Selinexor
Trials testing the same drug.
- 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 Smoldering Multiple Myeloma
Currently open trials in the same condition.
- NCT06365060 — Screening for AL Amyloidosis in Smoldering Multiple Myeloma · recruiting
- NCT05841550 — The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma · Phase 1, PHASE2 · recruiting
- NCT06383143 — Promoting Diagnosis and Management of AL in Italy (ProDigALIty) · recruiting
- NCT05767359 — CAR- PRISM (PRecision Intervention Smoldering Myeloma) · Phase 2 · active not recruiting
- NCT05469893 — Immuno-PRISM (PRecision Intervention Smoldering Myeloma) · Phase 2 · recruiting
Other University of Rochester trials
Trials by the same sponsor.
- NCT07075965 — Calcium Channel Blocker in Myotonic Dystrophy Type 1 · Phase 1 · not yet recruiting
- NCT07423104 — A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloi · Phase 2 · not yet recruiting
- NCT05744869 — SBAT for Health Equity · NA · not yet recruiting
- NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
- NCT07032636 — Reducing Crises and Suicide Within the Idaho Army National Guard · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05597345 (US National Library of Medicine, public domain)
- 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 University of Rochester
- Last refreshed: 10 February 2025
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/NCT05597345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing