根据发表于Journal of Clinical Oncology的 2期研究结果，泊马度胺加低剂量地塞米松改善了复发/难治性多发性骨髓瘤和中度至重度肾功能损害患者的反应。
The combination also appeared well tolerated.
“肾功能损害是多发性骨髓瘤的常见合并症。大约20％至30％的多发性骨髓瘤患者在诊断时出现肾功能损害，约10％需要透析，“ 雅典大学医学院临床治疗学教授兼主席Meletios Dimopoulos及其同事中写道。“随着时间的推移，患有多发性骨髓瘤的患者可能会出现肾功能损害，这与预后不良和生存期短有关。”
Median OS for these patients is 2 years.
Dimopoulos and colleagues enrolled 81 patients (median age, 72 years) with relapsed/refractory multiple myeloma in the noncomparative MM-013 trial.
Researchers categorized patients into three cohorts: moderate renal impairment (estimated glomerular filtration rate, 30 mL/min/1.73 m2 to 45 mL/min/1.73 m2), severe renal impairment (estimated glomerular filtration rate, less than 30 mL/min/1.73 m2) or severe renal impairment that requires hemodialysis.
Patients had undergone a median four prior antimyeloma regimens.
Patients received 4 mg pomalidomide (Pomalyst, Celgene) daily on days 1 to 21, and 20 mg or 40 mg dexamethasone once per week in 28-day cycles.
Overall response rate served as the primary endpoint. Median follow-up was 8.6 months.
ORR was 39.4% among patients with moderate renal impairment, 32.4% among those with severe impairment and 14.3% among those requiring hemodialysis.
Median duration of response was 14.7 months among those with moderate renal impairment and 4.6 months among those with severe renal impairment. Median duration of response had not been reached for those needing hemodialysis.
All patients with moderate renal impairment exhibited disease control, whereas 79.4% of patients with severe renal impairment and 78.6% of patients with severe renal impairment needing hemodialysis exhibited disease control.
Median OS was:
- • 16.4 months among patients with moderate renal impairment;
- • 11.8 months among patients with severe renal impairment; and
- 5.2 months among patients with severe renal impairment needing hemodialysis.
Researchers observed complete renal response among 18.2% of patients with moderate impairment.
No patients who required hemodialysis at baseline became dialysis independent.
Thirteen patients remained on treatment at data cutoff.
Sixteen percent of patients experienced adverse events that required dose reductions.
The most common grade 3 or grade 4 treatment-related adverse events included neutropenia (53.1%), anemia (35.8%), infections (32.1%), thrombocytopenia (27.2%), fatigue (6.2%), hyperkalemia (6.2%), renal failure (6.2%), hypocalcemia (4.9%), pyrexia (2.5%), and peripheral edema (1.2%).
“The MM-013 trial is the first study to provide evidence that these patients can benefit from treatment with pomalidomide plus low-dose dexamethasone and supports the use of this regimen [among] patients with relapsed/refractory multiple myeloma and severe renal impairment, including those receiving hemodialysis,” the researchers wrote. “Achieving disease control and stabilization has meaningful clinical benefits, particularly for patients who require hemodialysis.
“Results presented here add to the limited body of evidence of treatment options for patients with advanced stages of multiple myeloma and renal impairment and will help health care providers make appropriate treatment choices for this patient population,” they added.
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