A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Dexamethasone in Patients With Multiple Myeloma Exposed to Bortezomib, Carfilzomib, Lenalidomide and Pomalidomide and Refractory to an IMiD and a Proteasome Inhibitor

Patients with heavily pretreated, quad-exposed multiple myeloma (refractory to one PI and one IMiD) will receive selinexor 80 mg (45 mg/m2 BSA) plus low-dose dexamethasone (20 mg), both twice weekly.
Cancer (Oncology) - Multiple Myeloma, Cancer (Oncology)
William Bensinger, MD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:

    1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA; or
    2. Urinary M-protein excretion at least 200 mg/24 hours; or
    3. Serum Free Light Chain (FLC) whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal light chain ratio.
  • Patients must have received ≥ 3 prior anti-MM regimens including the following: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib and a glucocorticoid. There is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
  • Penta-refractory MM: 25% of patients must have MM refractory to lenalidomide, pomalidomide, bortezomib, carfilzomib, and at least one CD38 MAb (e.g., SAR 650984 or daratumumab)
  • Multiple myeloma refractory to the patient's most recent anti-MM regimen.

Exclusion Criteria:

  • Smoldering MM.
  • Plasma cell leukemia.
  • MM that does not express M-protein or FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or FLC are excluded).
  • Documented systemic amyloid light chain amyloidosis.
  • Active CNS MM.
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