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ELOTUZUMAB INJ,LYPHL

Clinical Criteria Summary

Laboratory & Hematologic Criteria

  • Exclusion: Hemoglobin < 8 g/dL; Must transfuse to hemoglobin above 8 gm/dL prior to therapy initiation
  • Exclusion: Absolute neutrophil count (ANC) < 1000/mm3
  • Exclusion: Platelet count < 50,000/mm3 (<30,000/mm3 if myeloma involvement in bone marrow > 50%)
  • Exclusion: Total bilirubin > 2x the upper limit of the normal range (except for Gilbert Syndrome: direct bilirubin > 2 mg/dL) or ALT and AST > 3x upper limit of normal

Clinical Status & Performance

  • Exclusion: Eastern Cooperative Oncology Group performance status > 2

Infection, Pregnancy & Lactation

  • Exclusion: Active or uncontrolled infection
  • Exclusion: Known pregnancy
  • Exclusion: Lactating

Diagnosis & Care Setting

  • Inclusion: Diagnosis of relapsed or refractory multiple myeloma, following at least one prior line of therapy
  • Inclusion: Care is provided by a VA or VA Community Care hematology/oncology provider

Palliative Care

  • Inclusion: Goals of care and role of Palliative Care consult have been discussed and documented

Contraception & REMS Compliance

  • Inclusion: Patients who can become pregnant and patients with partners who can become pregnant must comply with pregnancy testing and contraception requirements for lenalidomide or pomalidomide under their REMS programs

Source Documents