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Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials

Standard

Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. / Siegel, David S; Weisel, Katja C; Dimopoulos, Meletios A; Baz, Rachid; Richardson, Paul; Delforge, Michel; Song, Kevin W; San Miguel, Jesus F; Moreau, Philippe; Goldschmidt, Hartmut; Cavo, Michele; Jagannath, Sundar; Yu, Xin; Hong, Kevin; Sternas, Lars; Zaki, Mohamed; Palumbo, Antonio.

in: LEUKEMIA LYMPHOMA, Jahrgang 57, Nr. 12, 12.2016, S. 2833-2838.

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

Harvard

Siegel, DS, Weisel, KC, Dimopoulos, MA, Baz, R, Richardson, P, Delforge, M, Song, KW, San Miguel, JF, Moreau, P, Goldschmidt, H, Cavo, M, Jagannath, S, Yu, X, Hong, K, Sternas, L, Zaki, M & Palumbo, A 2016, 'Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials', LEUKEMIA LYMPHOMA, Jg. 57, Nr. 12, S. 2833-2838. https://doi.org/10.1080/10428194.2016.1177181

APA

Siegel, D. S., Weisel, K. C., Dimopoulos, M. A., Baz, R., Richardson, P., Delforge, M., Song, K. W., San Miguel, J. F., Moreau, P., Goldschmidt, H., Cavo, M., Jagannath, S., Yu, X., Hong, K., Sternas, L., Zaki, M., & Palumbo, A. (2016). Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. LEUKEMIA LYMPHOMA, 57(12), 2833-2838. https://doi.org/10.1080/10428194.2016.1177181

Vancouver

Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M et al. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. LEUKEMIA LYMPHOMA. 2016 Dez;57(12):2833-2838. https://doi.org/10.1080/10428194.2016.1177181

Bibtex

@article{675ffc6205324b1fa928a884a38de0a2,
title = "Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials",
abstract = "Renal impairment (RI) is a major comorbidity in patients with multiple myeloma (MM). Here we present the pooled safety and efficacy analysis of three clinical trials (MM-002, MM-003, and MM-010) of pomalidomide + low-dose dexamethasone (POM + LoDEX) in patients with moderate RI (creatinine clearance [CrCl] ≥ 30 to <60 mL/min) and without RI (≥ 60 mL/min). Trial protocols were approved by the institutional review board of each site involved. Patients with RI were older than patients without RI, although other baseline characteristics were similar. The dosing and safety profile of POM + LoDEX was similar across RI subgroups. Median overall response rate, progression-free survival, time to progression, and duration of response were not significantly different between RI subgroups. However, patients with vs. without RI had significantly shorter median overall survival (10.5 vs. 14.0 months, respectively; p = .004). This analysis demonstrates that POM + LoDEX is a safe and effective treatment for patients with moderate RI. The trials were registered at ClinicalTrials.gov as NCT00833833 (MM-002), NCT01311687 (MM-003), and NCT01712789 (MM-010) and at EudraCT as 2010-019820-30 (MM-003) and 2012-001888-78 (MM-010).",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Multiple Myeloma, Neoplasm Staging, Recurrence, Renal Insufficiency, Retreatment, Thalidomide, Treatment Outcome, Journal Article, Research Support, Non-U.S. Gov't",
author = "Siegel, {David S} and Weisel, {Katja C} and Dimopoulos, {Meletios A} and Rachid Baz and Paul Richardson and Michel Delforge and Song, {Kevin W} and {San Miguel}, {Jesus F} and Philippe Moreau and Hartmut Goldschmidt and Michele Cavo and Sundar Jagannath and Xin Yu and Kevin Hong and Lars Sternas and Mohamed Zaki and Antonio Palumbo",
year = "2016",
month = dec,
doi = "10.1080/10428194.2016.1177181",
language = "English",
volume = "57",
pages = "2833--2838",
journal = "LEUKEMIA LYMPHOMA",
issn = "1042-8194",
publisher = "informa healthcare",
number = "12",

}

RIS

TY - JOUR

T1 - Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials

AU - Siegel, David S

AU - Weisel, Katja C

AU - Dimopoulos, Meletios A

AU - Baz, Rachid

AU - Richardson, Paul

AU - Delforge, Michel

AU - Song, Kevin W

AU - San Miguel, Jesus F

AU - Moreau, Philippe

AU - Goldschmidt, Hartmut

AU - Cavo, Michele

AU - Jagannath, Sundar

AU - Yu, Xin

AU - Hong, Kevin

AU - Sternas, Lars

AU - Zaki, Mohamed

AU - Palumbo, Antonio

PY - 2016/12

Y1 - 2016/12

N2 - Renal impairment (RI) is a major comorbidity in patients with multiple myeloma (MM). Here we present the pooled safety and efficacy analysis of three clinical trials (MM-002, MM-003, and MM-010) of pomalidomide + low-dose dexamethasone (POM + LoDEX) in patients with moderate RI (creatinine clearance [CrCl] ≥ 30 to <60 mL/min) and without RI (≥ 60 mL/min). Trial protocols were approved by the institutional review board of each site involved. Patients with RI were older than patients without RI, although other baseline characteristics were similar. The dosing and safety profile of POM + LoDEX was similar across RI subgroups. Median overall response rate, progression-free survival, time to progression, and duration of response were not significantly different between RI subgroups. However, patients with vs. without RI had significantly shorter median overall survival (10.5 vs. 14.0 months, respectively; p = .004). This analysis demonstrates that POM + LoDEX is a safe and effective treatment for patients with moderate RI. The trials were registered at ClinicalTrials.gov as NCT00833833 (MM-002), NCT01311687 (MM-003), and NCT01712789 (MM-010) and at EudraCT as 2010-019820-30 (MM-003) and 2012-001888-78 (MM-010).

AB - Renal impairment (RI) is a major comorbidity in patients with multiple myeloma (MM). Here we present the pooled safety and efficacy analysis of three clinical trials (MM-002, MM-003, and MM-010) of pomalidomide + low-dose dexamethasone (POM + LoDEX) in patients with moderate RI (creatinine clearance [CrCl] ≥ 30 to <60 mL/min) and without RI (≥ 60 mL/min). Trial protocols were approved by the institutional review board of each site involved. Patients with RI were older than patients without RI, although other baseline characteristics were similar. The dosing and safety profile of POM + LoDEX was similar across RI subgroups. Median overall response rate, progression-free survival, time to progression, and duration of response were not significantly different between RI subgroups. However, patients with vs. without RI had significantly shorter median overall survival (10.5 vs. 14.0 months, respectively; p = .004). This analysis demonstrates that POM + LoDEX is a safe and effective treatment for patients with moderate RI. The trials were registered at ClinicalTrials.gov as NCT00833833 (MM-002), NCT01311687 (MM-003), and NCT01712789 (MM-010) and at EudraCT as 2010-019820-30 (MM-003) and 2012-001888-78 (MM-010).

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Dexamethasone

KW - Drug Resistance, Neoplasm

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Multiple Myeloma

KW - Neoplasm Staging

KW - Recurrence

KW - Renal Insufficiency

KW - Retreatment

KW - Thalidomide

KW - Treatment Outcome

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1080/10428194.2016.1177181

DO - 10.1080/10428194.2016.1177181

M3 - SCORING: Journal article

C2 - 27267105

VL - 57

SP - 2833

EP - 2838

JO - LEUKEMIA LYMPHOMA

JF - LEUKEMIA LYMPHOMA

SN - 1042-8194

IS - 12

ER -