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Bone-Modifying Agents in Multiple Myeloma

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• For those patients in whom bisphosphonates were withdrawn after 2 years, the drug should be resumed upon relapse with new-onset skeletal-related events. • Denosumab should NOT be stopped abruptly given its reversible mechanism of action. Monitoring ➤ The Expert Panel recommends that serum creatinine should be monitored before each dose of pamidronate or zoledronic acid, in accordance with FDA-approved labeling. • Denosumab does not require monitoring of renal function. ➤ In patients who develop renal deterioration without apparent cause during bisphosphonate therapy, zoledronic acid or pamidronate should be withheld. • Bisphosphonate therapy can be resumed, at the same dosage as that before treatment interruption, when the serum creatinine returns to within 10% of the baseline level. • Denosumab requires no dose modification. ➤ Serum calcium should be monitored regularly, and serum vitamin D levels should be evaluated intermittently. • Hypocalcemia is an adverse effect of all bone resorptive agents and is more pronounced with denosumab. • Patients should be calcium and vitamin D repleted. ➤ The Expert Panel also recommends intermittent evaluation (every 3–6 months) of all patients receiving pamidronate or zoledronic acid therapy for the presence of albuminuria on a spot urine sample. • In patients experiencing unexplained albuminuria, then a 24 hour urine should be obtained to assess for >500 mg/24 hours of urinary albumin, and discontinuation of the drug is advised until the renal problems are resolved. • These patients should be reassessed every 3–4 weeks (with a 24 hour urine collection for total protein and urine protein electrophoresis), and pamidronate should be reinstituted over a longer infusion time (≥4 hours) and at doses not to exceed 90 mg every 4 weeks when the renal function returns to baseline. ➤ The Expert Panel supports the use of screening urinalysis for proteinuria but underscores that a 24 hour urine collection for determination of total protein and electrophoresis is required if the test is positive. • Although no similar guidelines are available for zoledronic acid, some Expert Panel members recommend that zoledronic acid be reinstituted over a longer infusion time (≥30 minutes). Biochemical Markers ➤ The use of the biochemical markers of bone metabolism to monitor bone modifying therapy use is NOT suggested for routine care. Treatment

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