SELINEXOR TAB
Clinical Criteria Summary
Exclusion Criteria
- Inability to reliably take drug according to prescribed schedule
- Malabsorption syndrome or other condition affecting oral absorption
- Patient is not a candidate for dexamethasone therapy
- Active CNS disease
- Active, unstable cardiovascular function
- Ongoing or active systemic infection including hepatitis B or C, or known HIV
- ANC < 1000/mm3
- Platelet count < 75,000/mm3 (< 50,000/mm3 if myeloma involvement in bone marrow > 50%)
- Hemoglobin < 8 g/dL; Must transfuse to hemoglobin above 8 g/dL prior to initiation
- Total bilirubin > 2 x ULN (Gilbert’s syndrome > 3 x ULN) and AST and ALT > 2.5x ULN
- Estimated creatinine clearance < 15 ml/min
- Sodium level < 130 mmol/L
- Patient with evidence of anorexia and/or dehydration
- Concomitant therapy with antiplatelet drugs
- Unable to take antiemetic prophylaxis & breakthrough regimen for highly emetogenic therapy
- Pregnancy
- Breastfeeding
Inclusion Criteria (Indications)
- Multiple myeloma: In combination with bortezomib and dexamethasone after at least one prior line of therapy
- Relapsed or refractory multiple myeloma: In combination with dexamethasone after at least 4 prior myeloma therapies (unless contraindicated or patient is unable to tolerate), with disease refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody
- Relapsed or refractory Diffuse Large B-cell lymphoma: After at least 2 prior lines of therapy
Additional Inclusion Criteria
- Care provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult discussed and documented
- ECOG performance status < 2
- Patients of child-bearing potential or with partners of child-bearing potential: Counseling provided on risk vs. benefit regarding pregnancy; Continue effective contraception until 1 week after last dose