THE CHALLENGE OF RENAL IMPAIRMENT
Renal Infufficiency Is a Frequent, Often Severe Complication in Patients with Multiple Myeloma (MM)
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Derived from 2 studies reviewing 2,128 cases of newly diagnosed
multiple myeloma
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In the same patient population, when evaluated using estimated
creatinine clearance, nearly 50% of patients had impaired renal
function3,4
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Renal Impairment Significantly Affects the Prognosis of Patients with MM3-5
Elevated serum creatinine is associated with shorter survival
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In a univariate analysis of the records of all patients diagnosed with multiple myeloma at the Mayo Clinic in Rochester, Minn (N = 1,027), patients with serum creatinine ≥ 2 mg/dL had a shorter median
survival compared with those with normal renal function (21
months versus 36 months)5
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RESULTS IN PATIENTS WITH RENAL IMPAIRMENT*
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Clinical studies include patients with creatinine clearance as low as
13.8 mL/min
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Dyspnea was the only adverse event significantly higher in patients
with creatinine clearance less than 50 mL/min
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Patients with renal impairment should be closely monitored for
toxicities during treatment with VELCADE
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Clinical Data in Patients with Varying Degrees of Renal Insufficiency, Including Dialysis Dependency‡
An NCI/CTEP organ dysfunction study of 51 patients with advanced
malignancies and renal insufficiency demonstrated:
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Pharmacokinetics were not influenced by the degree of renal impairment
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* A retrospective analysis of phase 2 trials, including CREST and SUMMIT. CREST was a small, open-label, multicenter, dose-ranging trial of 54 multiple myeloma patients who were relapsed or refractory after 1 prior therapy (median 3 prior therapies); patients were randomized to receive a 1.0 mg/m2 or 1.3 mg/m2 twice weekly dose of VELCADE for 2 weeks followed by a 10-day rest period. The SUMMIT trial was a phase 2, single-arm, open-label, multicenter clinical trial of 202 (188 evaluable) relapsed/refractory multiple myeloma patients who had received at least 2 prior therapies and had demonstrated disease progression on the last therapy (with a median of 6 prior therapies). Patients received 1.3 mg/m2 dose of VELCADE twice weekly for 2 weeks followed by a 10-day period.
†Complete response (CR) required 100% disappearance of the original myeloma protein from blood and urine on at least 2 determinations 6 weeks apart by immunofixation, less than 5% plasma cells in the bone marrow, stable bone disease, and normal calcium. Near complete response (nCR) required that all CR criteria be met except that immunofixation was positive. Partial response (PR) required ≥ 50% reduction in serum myeloma protein and ≥ 90% reduction in urine myeloma protein on at least 2 determinations 6 weeks apart, stable bone disease and normal calcium. Minimal response (MR) required 25-49% reduction in serum myeloma protein and 50-89% reduction in urine myeloma protein on at least 2 determinations 6 weeks apart, stable bone disease.
‡VELCADE was given in escalating doses of 0.7 mg/m2-1.3 mg/m2 in patients with varying degrees of renal insufficiency including dialysis dependency. Pharmacokinetics and pharmacodynamics were measured in each subgroup. The study is currently open at the 1.3 mg/m2 dose level in severe and dialysis patients.
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