Practical clinical guidelines when administering DARA and ELO
| DARA Pretreatment Infectious disease prophylaxis Pulmonary function testing RBC compatibility testing Premedications | Begin VZV prophylaxis 1 week prior to DARA administration and for 3 months posttreatment |
| Perform pulmonary function testing in patients with history of severe COPD or moderate-to-severe reactive airway disease. If FEV1 <50%, strong caution advised in administering DARA because clinical studies with DARA excluded such patients | |
| Notify local blood bank that patient will be receiving anti–CD38-directed therapy | |
| Perform RBC phenotyping (or genotyping prior if patient has received RBC transfusion within 3 months) prior to 1st dose of DARA | |
| Provide wallet card for patient to inform blood banks and physicians of potential interference with RBC compatibility testing due to anti–CD38-directed therapy | |
| IV corticosteroids (methylprednisolone 100 mg prior to doses 1 and 2, 60 mg for subsequent doses or equivalent) | |
| Oral antipyretic (acetaminophen 650 mg to 1000 mg or equivalent) | |
| Oral or IV H1 receptor antagonist (diphenhydramine 25 to 50 mg or equivalent) | |
| Strongly consider: | |
| Oral or IV H2 receptor antagonist (famotidine 20 mg or equivalent) | |
| Oral leukotriene receptor antagonist (montelukast 10 mg or equivalent) | |
| If FEV1 ≤80%, administer β2-adrenergic agonist inhaler | |
| For at-risk patients for IRR, consider admitting to hospital for first dose of DARA for careful monitoring | |
| Treatment IRR | Hold infusion of DARA until symptoms resolve; administer corticosteroids, antihistamines and bronchodilators as needed. Restart infusion at 1/2 rate of when IRR began and can increase as patient tolerates to maximum rate of 200 mL/min |
| Post-treatment Posttreatment prophylaxis Response assessments with SPEP and IFE Plasma cell quantification with flow cytometry ELO Pretreatment Infectious disease prophylaxis Premedications Treatment IRR Posttreatment Response assessments with SPEP and IFE | Oral corticosteroids for 2 days after each DARA infusion (DEX 4 mg or equivalent) |
| If FEV1 ≤80%, continue β2-adrenergic agonist inhaler | |
| If M protein <0.2 g/dL, use DARA IFE reflex assay to discriminate between disease-related M protein and drug-related M protein to assess for CR Use alternative cell surface marker other than CD38 as a marker for plasma cell identification or use CD38 antibody that binds to different epitope than DARA for up to 6 months after treatment is completed Begin VZV prophylaxis 1 week prior to ELO administration and for 3 months posttreatment Oral DEX 28 mg 3 to 24 hours prior to each ELO dose IV DEX 8 mg 45 to 90 minutes prior to each ELO dose Oral antipyretic (acetaminophen 650 mg to 1000 mg or equivalent) Oral or IV H1 receptor antagonist (diphenhydramine 25 to 50 mg or equivalent) Oral or IV H2 receptor antagonist (ranitidine 150 mg PO or 50 mg IV or equivalent) Hold infusion of ELO until symptoms resolve to grade 1 or lower; administer corticosteroids, antihistamines, and bronchodilators as needed. Restart infusion at 0.5 mL/min and gradually increase by 0.5 mL/min every 30 minutes until target rate of 2 mL/min Assessment of CR with SPEP and IFE can be impaired due to co-migration of ELO band with disease-related M protein. Commercial anti-ELO antibodies for SPEP and IFE assays are in development to discriminate between ELO and endogenous M protein | |
| DARA Pretreatment Infectious disease prophylaxis Pulmonary function testing RBC compatibility testing Premedications | Begin VZV prophylaxis 1 week prior to DARA administration and for 3 months posttreatment |
| Perform pulmonary function testing in patients with history of severe COPD or moderate-to-severe reactive airway disease. If FEV1 <50%, strong caution advised in administering DARA because clinical studies with DARA excluded such patients | |
| Notify local blood bank that patient will be receiving anti–CD38-directed therapy | |
| Perform RBC phenotyping (or genotyping prior if patient has received RBC transfusion within 3 months) prior to 1st dose of DARA | |
| Provide wallet card for patient to inform blood banks and physicians of potential interference with RBC compatibility testing due to anti–CD38-directed therapy | |
| IV corticosteroids (methylprednisolone 100 mg prior to doses 1 and 2, 60 mg for subsequent doses or equivalent) | |
| Oral antipyretic (acetaminophen 650 mg to 1000 mg or equivalent) | |
| Oral or IV H1 receptor antagonist (diphenhydramine 25 to 50 mg or equivalent) | |
| Strongly consider: | |
| Oral or IV H2 receptor antagonist (famotidine 20 mg or equivalent) | |
| Oral leukotriene receptor antagonist (montelukast 10 mg or equivalent) | |
| If FEV1 ≤80%, administer β2-adrenergic agonist inhaler | |
| For at-risk patients for IRR, consider admitting to hospital for first dose of DARA for careful monitoring | |
| Treatment IRR | Hold infusion of DARA until symptoms resolve; administer corticosteroids, antihistamines and bronchodilators as needed. Restart infusion at 1/2 rate of when IRR began and can increase as patient tolerates to maximum rate of 200 mL/min |
| Post-treatment Posttreatment prophylaxis Response assessments with SPEP and IFE Plasma cell quantification with flow cytometry ELO Pretreatment Infectious disease prophylaxis Premedications Treatment IRR Posttreatment Response assessments with SPEP and IFE | Oral corticosteroids for 2 days after each DARA infusion (DEX 4 mg or equivalent) |
| If FEV1 ≤80%, continue β2-adrenergic agonist inhaler | |
| If M protein <0.2 g/dL, use DARA IFE reflex assay to discriminate between disease-related M protein and drug-related M protein to assess for CR Use alternative cell surface marker other than CD38 as a marker for plasma cell identification or use CD38 antibody that binds to different epitope than DARA for up to 6 months after treatment is completed Begin VZV prophylaxis 1 week prior to ELO administration and for 3 months posttreatment Oral DEX 28 mg 3 to 24 hours prior to each ELO dose IV DEX 8 mg 45 to 90 minutes prior to each ELO dose Oral antipyretic (acetaminophen 650 mg to 1000 mg or equivalent) Oral or IV H1 receptor antagonist (diphenhydramine 25 to 50 mg or equivalent) Oral or IV H2 receptor antagonist (ranitidine 150 mg PO or 50 mg IV or equivalent) Hold infusion of ELO until symptoms resolve to grade 1 or lower; administer corticosteroids, antihistamines, and bronchodilators as needed. Restart infusion at 0.5 mL/min and gradually increase by 0.5 mL/min every 30 minutes until target rate of 2 mL/min Assessment of CR with SPEP and IFE can be impaired due to co-migration of ELO band with disease-related M protein. Commercial anti-ELO antibodies for SPEP and IFE assays are in development to discriminate between ELO and endogenous M protein | |
COPD, chronic obstructive pulmonary disease; VZV, varicella-zoster virus.