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OncoMatch/Clinical Trials/NCT05597345

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Is NCT05597345 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Selinexor for smoldering multiple myeloma.

Phase 2RecruitingUniversity of RochesterNCT05597345Data as of May 2026

Treatment: SelinexorSelinexor 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: SINE compound (Selinexor)

Prior exposure to a SINE compound, including Selinexor.

Lab requirements

Blood counts

Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)>=1.5 x10^9/L, hemoglobin >=10g/dL, platelets >/150x10^9/L.

Kidney function

Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl >= 15 mL/min.

Liver function

normal hepatic function within 28 days prior to C1D1

normal hepatic function within 28 days prior to C1D1; Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl >= 15 mL/min.; Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)>=1.5 x10^9/L, hemoglobin >=10g/dL, platelets >/150x10^9/L.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Rochester · Rochester, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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