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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

Qualifiers

Age >/= 18 years

Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein >/= 3 g/dL or BMPC >10% but <60%, or both.

Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder.

BMPC>/=20%

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Selinexor

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Rochester

Lead sponsor

Karyopharm Therapeutics Inc

Collaborator