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Pomalidomide, low-dose dexamethasone active in multiple myeloma with renal impairment
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Pomalidomide plus low-dose dexamethasone improved responses among patients with relapsed/refractory multiple myeloma and moderate to severe renal impairment, according to results from a phase 2 study published in Journal of Clinical Oncology.
The combination also appeared well tolerated.
“Renal impairment is a common comorbidity of multiple myeloma. Approximately 20% to 30% of patients with multiple myeloma present with renal impairment at diagnosis, with approximately 10% requiring dialysis,” Meletios Dimopoulos, MD, professor and chairman of the department of clinical therapeutics at University of Athens School of Medicine, and colleagues wrote. “Over time, patients with multiple myeloma may develop renal impairment, which is associated with poor prognosis and short survival.”
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. – by Cassie Homer
Disclosures: Dimopoulos reports honoraria from Amgen, Bristol-Myers Squibb, Celgene, Genesis Pharmaceuticals, Janssen-Cilag, Novartis and Takeda; consultant roles with Amgen, Celgene, Janssen-Cilag, and Takeda; institutional research funding from Amgen and Janssen-Cilag; and travel expenses from Amgen, Genesis Pharmaceuticals and Janssen-Ortho. Please see the study for all other authors’ relevant financial disclosures.
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