Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma (NCT05597345)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (19 items).
Location: University of Rochester — Rochester, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder
- Hypercalcemia (corrected serum calcium \>11.0 mg/dL)
- Renal insufficiency (creatinine \>2.0 mg/dL)
- Anemia (hemoglobin \<10g/dL)
- One or more osteolytic bone lesions on radiography, but more than one lesion required if \<10% clonal bone marrow plasma cells. Based on MRI imaging, there must be more than one lesion \>5mm in size.
- Clonal bone marrow plasma cells ≥60%
- An involved serum free light chain ≥ 100mg/L with the ratio of the involved/uninvolved free light chains also ≥100
- Documented systemic light chain amyloidosis
- Systemic corticosteroids \>10mg prednisone (or equivalent) daily for other medical conditions.
- Active invasive malignancy within the past 3 years that may affect the results or interfere with the interpretation of results of this study.
- Non-invasive malignancy that was not treated with curative intent within the past 3 years that may affect the results or interfere with the interpretation of the results of this study.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Rochester — Rochester, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.