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Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial

Standard

Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. / Dimopoulos, Meletios; Weisel, Katja; van de Donk, Niels W C J; Ramasamy, Karthik; Gamberi, Barbara; Streetly, Matthew; Offidani, Massimo; Bridoux, Frank; de la Rubia, Javier; Mateos, Maria-Victoria; Ardizzoia, Antonio; Kueenburg, Elisabeth; Collins, Shona; Di Micco, Antonia; Rosettani, Barbara; Li, Yan; Bacon, Pamela; Sonneveld, Pieter.

in: J CLIN ONCOL, Jahrgang 36, Nr. 20, 10.07.2018, S. 2035-2043.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Dimopoulos, M, Weisel, K, van de Donk, NWCJ, Ramasamy, K, Gamberi, B, Streetly, M, Offidani, M, Bridoux, F, de la Rubia, J, Mateos, M-V, Ardizzoia, A, Kueenburg, E, Collins, S, Di Micco, A, Rosettani, B, Li, Y, Bacon, P & Sonneveld, P 2018, 'Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial', J CLIN ONCOL, Jg. 36, Nr. 20, S. 2035-2043. https://doi.org/10.1200/JCO.2017.76.1742

APA

Dimopoulos, M., Weisel, K., van de Donk, N. W. C. J., Ramasamy, K., Gamberi, B., Streetly, M., Offidani, M., Bridoux, F., de la Rubia, J., Mateos, M-V., Ardizzoia, A., Kueenburg, E., Collins, S., Di Micco, A., Rosettani, B., Li, Y., Bacon, P., & Sonneveld, P. (2018). Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. J CLIN ONCOL, 36(20), 2035-2043. https://doi.org/10.1200/JCO.2017.76.1742

Vancouver

Dimopoulos M, Weisel K, van de Donk NWCJ, Ramasamy K, Gamberi B, Streetly M et al. Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. J CLIN ONCOL. 2018 Jul 10;36(20):2035-2043. https://doi.org/10.1200/JCO.2017.76.1742

Bibtex

@article{9dc342aa6b9046ae8affe93b6cade52c,
title = "Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial",
abstract = "Purpose Renal impairment (RI) limits treatment options in patients with relapsed/refractory multiple myeloma (RRMM). Here, we prospectively studied pomalidomide plus low-dose dexamethasone (LoDEX) in patients with RRMM and moderate or severe RI, including those receiving hemodialysis. Patients and Methods MM-013, a noncomparative, European phase II trial, enrolled three patient cohorts: moderate RI (cohort A; estimated glomerular filtration rate, 30 to < 45 mL/min/1.73 m2); severe RI (cohort B; estimated glomerular filtration rate, < 30 mL/min/1.73 m2); and severe RI that requires hemodialysis (cohort C). Patients received pomalidomide 4 mg/d on days 1 to 21 and LoDEX 20 or 40 mg once per week in 28-day cycles. The primary end point was overall response rate. Results Of 81 enrolled patients (33, 34, and 14 patients in cohorts A, B, and C, respectively), 13 were still receiving treatment at data cutoff (January 28, 2017). Overall response rates were 39.4%, 32.4%, and 14.3%, with a median duration of response of 14.7 months, 4.6 months, and not estimable, respectively. Of importance, 100%, 79.4%, and 78.6% of patients, respectively, achieved disease control. With a median follow-up of 8.6 months, median overall survival was 16.4 months, 11.8 months, and 5.2 months, respectively. Complete renal responses were observed only in cohort A (18.2%), and no patients in cohort C became hemodialysis independent. Grade 3 and 4 hematologic treatment-emergent adverse events and pomalidomide discontinuations as a result of treatment-emergent adverse events occurred more frequently in cohort C. Pomalidomide pharmacokinetics were comparable among the three renal cohorts. Conclusion Pomalidomide 4 mg/d plus LoDEX is efficacious in patients with RRMM with moderate or severe RI, including those who had more advanced disease and required hemodialysis. The safety profile was acceptable among the three groups, and no new safety signals were observed.",
keywords = "Journal Article",
author = "Meletios Dimopoulos and Katja Weisel and {van de Donk}, {Niels W C J} and Karthik Ramasamy and Barbara Gamberi and Matthew Streetly and Massimo Offidani and Frank Bridoux and {de la Rubia}, Javier and Maria-Victoria Mateos and Antonio Ardizzoia and Elisabeth Kueenburg and Shona Collins and {Di Micco}, Antonia and Barbara Rosettani and Yan Li and Pamela Bacon and Pieter Sonneveld",
year = "2018",
month = jul,
day = "10",
doi = "10.1200/JCO.2017.76.1742",
language = "English",
volume = "36",
pages = "2035--2043",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "20",

}

RIS

TY - JOUR

T1 - Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial

AU - Dimopoulos, Meletios

AU - Weisel, Katja

AU - van de Donk, Niels W C J

AU - Ramasamy, Karthik

AU - Gamberi, Barbara

AU - Streetly, Matthew

AU - Offidani, Massimo

AU - Bridoux, Frank

AU - de la Rubia, Javier

AU - Mateos, Maria-Victoria

AU - Ardizzoia, Antonio

AU - Kueenburg, Elisabeth

AU - Collins, Shona

AU - Di Micco, Antonia

AU - Rosettani, Barbara

AU - Li, Yan

AU - Bacon, Pamela

AU - Sonneveld, Pieter

PY - 2018/7/10

Y1 - 2018/7/10

N2 - Purpose Renal impairment (RI) limits treatment options in patients with relapsed/refractory multiple myeloma (RRMM). Here, we prospectively studied pomalidomide plus low-dose dexamethasone (LoDEX) in patients with RRMM and moderate or severe RI, including those receiving hemodialysis. Patients and Methods MM-013, a noncomparative, European phase II trial, enrolled three patient cohorts: moderate RI (cohort A; estimated glomerular filtration rate, 30 to < 45 mL/min/1.73 m2); severe RI (cohort B; estimated glomerular filtration rate, < 30 mL/min/1.73 m2); and severe RI that requires hemodialysis (cohort C). Patients received pomalidomide 4 mg/d on days 1 to 21 and LoDEX 20 or 40 mg once per week in 28-day cycles. The primary end point was overall response rate. Results Of 81 enrolled patients (33, 34, and 14 patients in cohorts A, B, and C, respectively), 13 were still receiving treatment at data cutoff (January 28, 2017). Overall response rates were 39.4%, 32.4%, and 14.3%, with a median duration of response of 14.7 months, 4.6 months, and not estimable, respectively. Of importance, 100%, 79.4%, and 78.6% of patients, respectively, achieved disease control. With a median follow-up of 8.6 months, median overall survival was 16.4 months, 11.8 months, and 5.2 months, respectively. Complete renal responses were observed only in cohort A (18.2%), and no patients in cohort C became hemodialysis independent. Grade 3 and 4 hematologic treatment-emergent adverse events and pomalidomide discontinuations as a result of treatment-emergent adverse events occurred more frequently in cohort C. Pomalidomide pharmacokinetics were comparable among the three renal cohorts. Conclusion Pomalidomide 4 mg/d plus LoDEX is efficacious in patients with RRMM with moderate or severe RI, including those who had more advanced disease and required hemodialysis. The safety profile was acceptable among the three groups, and no new safety signals were observed.

AB - Purpose Renal impairment (RI) limits treatment options in patients with relapsed/refractory multiple myeloma (RRMM). Here, we prospectively studied pomalidomide plus low-dose dexamethasone (LoDEX) in patients with RRMM and moderate or severe RI, including those receiving hemodialysis. Patients and Methods MM-013, a noncomparative, European phase II trial, enrolled three patient cohorts: moderate RI (cohort A; estimated glomerular filtration rate, 30 to < 45 mL/min/1.73 m2); severe RI (cohort B; estimated glomerular filtration rate, < 30 mL/min/1.73 m2); and severe RI that requires hemodialysis (cohort C). Patients received pomalidomide 4 mg/d on days 1 to 21 and LoDEX 20 or 40 mg once per week in 28-day cycles. The primary end point was overall response rate. Results Of 81 enrolled patients (33, 34, and 14 patients in cohorts A, B, and C, respectively), 13 were still receiving treatment at data cutoff (January 28, 2017). Overall response rates were 39.4%, 32.4%, and 14.3%, with a median duration of response of 14.7 months, 4.6 months, and not estimable, respectively. Of importance, 100%, 79.4%, and 78.6% of patients, respectively, achieved disease control. With a median follow-up of 8.6 months, median overall survival was 16.4 months, 11.8 months, and 5.2 months, respectively. Complete renal responses were observed only in cohort A (18.2%), and no patients in cohort C became hemodialysis independent. Grade 3 and 4 hematologic treatment-emergent adverse events and pomalidomide discontinuations as a result of treatment-emergent adverse events occurred more frequently in cohort C. Pomalidomide pharmacokinetics were comparable among the three renal cohorts. Conclusion Pomalidomide 4 mg/d plus LoDEX is efficacious in patients with RRMM with moderate or severe RI, including those who had more advanced disease and required hemodialysis. The safety profile was acceptable among the three groups, and no new safety signals were observed.

KW - Journal Article

U2 - 10.1200/JCO.2017.76.1742

DO - 10.1200/JCO.2017.76.1742

M3 - SCORING: Journal article

C2 - 29394124

VL - 36

SP - 2035

EP - 2043

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 20

ER -