Pharmacokinetics and Safety of Elotuzumab Combined With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma and Various Levels of Renal Impairment: Results of a Phase Ib Study
Micro-Abstract Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of elotuzumab, a humanized IgG1 monoclonal antibody, combined with lenalidomide and dexamethasone, is not significantly different be...
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| Published in | Clinical lymphoma, myeloma and leukemia Vol. 16; no. 3; pp. 129 - 138 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
Elsevier Inc
01.03.2016
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| Abstract | Micro-Abstract Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of elotuzumab, a humanized IgG1 monoclonal antibody, combined with lenalidomide and dexamethasone, is not significantly different between patients with MM with and without renal impairment, suggesting that elotuzumab might be administered without dose adjustment for renal function. |
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| AbstractList | Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of elotuzumab, a humanized IgG1 monoclonal antibody, combined with lenalidomide and dexamethasone, is not significantly different between patients with MM with and without renal impairment, suggesting that elotuzumab might be administered without dose adjustment for renal function.
The present study evaluated the pharmacokinetics and safety of elotuzumab, a humanized IgG1 monoclonal antibody against signaling lymphocyte activation molecule-F7, combined with lenalidomide and dexamethasone, in patients with multiple myeloma (MM) and renal impairment.
Patients with MM and normal renal function (NRF) (creatinine clearance [CrCl] ≥ 90 mL/min), severe renal impairment (SRI) (CrCl < 30 mL/min, not requiring dialysis), or end-stage renal disease (ESRD) (requiring dialysis) were enrolled in this open-label, phase Ib study. Elotuzumab (10 mg/kg), lenalidomide (5-25 mg), and dexamethasone (40 mg) were administered in 28-day cycles until disease progression or unacceptable toxicity developed. The primary endpoint was single-dose elotuzumab pharmacokinetics.
A total of 26 patients (median age, 63 years) were treated (NRF, n = 8; SRI, n = 9; ESRD, n = 9). The median baseline CrCl was 105 mL/min (range, 84-146 mL/min) for those with NRF and 26 mL/min (range, 15-33 mL/min) for those with SRI. Twenty-three patients (89%) had received previous therapy (median, 2 regimens; range, 1-7). Treatment was discontinued in 6 patients with NRF, 4 with SRI, and 5 with ESRD, primarily because of disease progression. The mean elotuzumab serum concentrations were comparable across groups (n = 23). No statistically significant differences were observed in the maximum observed serum concentration, area under the concentration–time curve from time 0 to the last quantifiable serum concentration, or area under the concentration–time curve from time 0 to infinity when the SRI and ESRD groups were compared with the NRF group (P > .05). All patients had ≥ 1 adverse event (AE). Of the 8 patients with NRF, 9 with SRI, and 9 with ESRD, 7, 8, and 7 experienced grade 3 to 4 AEs. The overall response rates were 75% in the NRF, 67% in the SRI, and 56% in the ESRD groups.
The results of the present study support the use of elotuzumab for the treatment of patients with MM and renal dysfunction without dose adjustment. The present study evaluated the pharmacokinetics and safety of elotuzumab, a humanized IgG1 monoclonal antibody against signaling lymphocyte activation molecule-F7, combined with lenalidomide and dexamethasone, in patients with multiple myeloma (MM) and renal impairment. Patients with MM and normal renal function (NRF) (creatinine clearance [CrCl] ≥ 90 mL/min), severe renal impairment (SRI) (CrCl < 30 mL/min, not requiring dialysis), or end-stage renal disease (ESRD) (requiring dialysis) were enrolled in this open-label, phase Ib study. Elotuzumab (10 mg/kg), lenalidomide (5-25 mg), and dexamethasone (40 mg) were administered in 28-day cycles until disease progression or unacceptable toxicity developed. The primary endpoint was single-dose elotuzumab pharmacokinetics. A total of 26 patients (median age, 63 years) were treated (NRF, n = 8; SRI, n = 9; ESRD, n = 9). The median baseline CrCl was 105 mL/min (range, 84-146 mL/min) for those with NRF and 26 mL/min (range, 15-33 mL/min) for those with SRI. Twenty-three patients (89%) had received previous therapy (median, 2 regimens; range, 1-7). Treatment was discontinued in 6 patients with NRF, 4 with SRI, and 5 with ESRD, primarily because of disease progression. The mean elotuzumab serum concentrations were comparable across groups (n = 23). No statistically significant differences were observed in the maximum observed serum concentration, area under the concentration-time curve from time 0 to the last quantifiable serum concentration, or area under the concentration-time curve from time 0 to infinity when the SRI and ESRD groups were compared with the NRF group (P > .05). All patients had ≥ 1 adverse event (AE). Of the 8 patients with NRF, 9 with SRI, and 9 with ESRD, 7, 8, and 7 experienced grade 3 to 4 AEs. The overall response rates were 75% in the NRF, 67% in the SRI, and 56% in the ESRD groups. The results of the present study support the use of elotuzumab for the treatment of patients with MM and renal dysfunction without dose adjustment. Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of elotuzumab, a humanized IgG1 monoclonal antibody, combined with lenalidomide and dexamethasone, is not significantly different between patients with MM with and without renal impairment, suggesting that elotuzumab might be administered without dose adjustment for renal function. Micro-Abstract Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of elotuzumab, a humanized IgG1 monoclonal antibody, combined with lenalidomide and dexamethasone, is not significantly different between patients with MM with and without renal impairment, suggesting that elotuzumab might be administered without dose adjustment for renal function. |
| Author | Bleickardt, Eric Vij, Ravi Gupta, Manish Zonder, Jeffrey Tendolkar, Amol Badros, Ashraf Paliwal, Prashni Berdeja, Jesus Lynch, Mark Kaufman, Jonathan L Jagannath, Sundar Manges, Robert |
| AuthorAffiliation | 8 Bristol-Myers Squibb, Wallingford, CT 3 Department of Oncology, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI 7 Bristol-Myers Squibb, Princeton, NJ 4 University of Maryland, Baltimore, MD 9 Division of Hematology and Oncology, Washington University School of Medicine, St. Louis, MO 5 Winship Cancer Institute, Emory University, Atlanta, GA 6 Investigative Clinical Research of Indiana, Indianapolis, IN 1 Sarah Cannon Research Institute, Nashville, TN 2 Mount Sinai Hospital, New York, NY |
| AuthorAffiliation_xml | – name: 7 Bristol-Myers Squibb, Princeton, NJ – name: 2 Mount Sinai Hospital, New York, NY – name: 8 Bristol-Myers Squibb, Wallingford, CT – name: 4 University of Maryland, Baltimore, MD – name: 9 Division of Hematology and Oncology, Washington University School of Medicine, St. Louis, MO – name: 6 Investigative Clinical Research of Indiana, Indianapolis, IN – name: 5 Winship Cancer Institute, Emory University, Atlanta, GA – name: 1 Sarah Cannon Research Institute, Nashville, TN – name: 3 Department of Oncology, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI |
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| Keywords | End-stage renal disease SLAMF7 Monoclonal antibody Creatinine clearance Glomerular filtration rate |
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| Snippet | Micro-Abstract Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The... Renal impairment is associated with a poor prognosis in patients with multiple myeloma (MM), and more treatment options are needed. The pharmacokinetics of... The present study evaluated the pharmacokinetics and safety of elotuzumab, a humanized IgG1 monoclonal antibody against signaling lymphocyte activation... |
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| SubjectTerms | Adult Aged Aged, 80 and over Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Creatinine clearance Cytogenetic Analysis Dexamethasone - administration & dosage Dexamethasone - pharmacokinetics End-stage renal disease Female Glomerular filtration rate Hematology, Oncology and Palliative Medicine Humans Kidney Diseases - complications Kidney Diseases - diagnosis Kidney Diseases - physiopathology Kidney Function Tests Male Middle Aged Monoclonal antibody Multiple Myeloma - complications Multiple Myeloma - diagnosis Multiple Myeloma - drug therapy Multiple Myeloma - mortality Neoplasm Staging Retreatment Severity of Illness Index SLAMF7 Thalidomide - administration & dosage Thalidomide - analogs & derivatives Thalidomide - pharmacokinetics Treatment Outcome |
| Title | Pharmacokinetics and Safety of Elotuzumab Combined With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma and Various Levels of Renal Impairment: Results of a Phase Ib Study |
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