ISATUXIMAB-IRFC INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Unable to be observed in clinic for an extended period following the first dose
- Absolute neutrophil count (ANC) < 1000/mm3
- Hemoglobin < 8 g/dL; Must transfuse to hemoglobin above 8 g/dL prior to therapy initiation
- Platelet count < 50,000/mm3 (<30,000/mm3 if myeloma involvement in bone barrow >50%)
- Active or uncontrolled infection
- Known pregnancy
- Lactating
Inclusion Criteria (Indications & Regimens)
- Previously treated multiple myeloma, as part of a pomalidomide- or carfilzomib-based regimen
- Newly diagnosed multiple myeloma, in combination with bortezomib, lenalidomide and dexamethasone, in transplant ineligible patients
Additional Inclusion Criteria (All Must Be Met)
- Care is provided by a VA or VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult has been discussed and documented
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Type and screen patients for Red Blood Cell antibodies PRIOR to starting therapy
- Provider has informed Blood Bank that patient will be starting isatuximab
Additional Inclusion Criteria (Select if Applicable)
- Female patients of child-bearing potential: counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for 5 months after stopping treatment
- Male patients with female partners of child-bearing potential: counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for 5 months after stopping treatment