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Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma

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Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. / Weisel, Katja C; Dimopoulos, Meletios A; Moreau, Philippe; Lacy, Martha Q; Song, Kevin W; Delforge, Michel; Karlin, Lionel; Goldschmidt, Hartmut; Banos, Anne; Oriol, Albert; Alegre, Adrian; Chen, Christine; Cavo, Michele; Garderet, Laurent; Ivanova, Valentina; Martinez-Lopez, Joaquin; Knop, Stefan; Yu, Xin; Hong, Kevin; Sternas, Lars; Jacques, Christian; Zaki, Mohamed H; San Miguel, Jesus.

in: HAEMATOLOGICA, Jahrgang 101, Nr. 7, 07.2016, S. 872-8.

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

Harvard

Weisel, KC, Dimopoulos, MA, Moreau, P, Lacy, MQ, Song, KW, Delforge, M, Karlin, L, Goldschmidt, H, Banos, A, Oriol, A, Alegre, A, Chen, C, Cavo, M, Garderet, L, Ivanova, V, Martinez-Lopez, J, Knop, S, Yu, X, Hong, K, Sternas, L, Jacques, C, Zaki, MH & San Miguel, J 2016, 'Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma', HAEMATOLOGICA, Jg. 101, Nr. 7, S. 872-8. https://doi.org/10.3324/haematol.2015.137083

APA

Weisel, K. C., Dimopoulos, M. A., Moreau, P., Lacy, M. Q., Song, K. W., Delforge, M., Karlin, L., Goldschmidt, H., Banos, A., Oriol, A., Alegre, A., Chen, C., Cavo, M., Garderet, L., Ivanova, V., Martinez-Lopez, J., Knop, S., Yu, X., Hong, K., ... San Miguel, J. (2016). Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. HAEMATOLOGICA, 101(7), 872-8. https://doi.org/10.3324/haematol.2015.137083

Vancouver

Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M et al. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. HAEMATOLOGICA. 2016 Jul;101(7):872-8. https://doi.org/10.3324/haematol.2015.137083

Bibtex

@article{07126b64dc6647a7a297549e1f7dfd88,
title = "Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma",
abstract = "Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 - < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 - < 60 mL/min (P<0.001) and 4.0 versus 2.0 months in the group with baseline creatinine clearance ≥ 60 mL/min (P<0.001). Median overall survival for pomalidomide + low-dose dexamethasone versus high-dose dexamethasone was 10.4 versus 4.9 months (P=0.030) and 15.5 versus 9.2 months (P=0.133), respectively. Improved renal function, defined as an increase in creatinine clearance from < 60 to ≥ 60 mL/min, was similar in pomalidomide + low-dose dexamethasone and high-dose dexamethasone patients (42% and 47%, respectively). Improvement in progression-free and overall survival in these patients was comparable with that in patients without renal impairment. There was no increase in discontinuations of therapy, dose modifications, and adverse events in patients with moderate renal impairment. Pomalidomide at a starting dose of 4 mg + low-dose dexamethasone is well tolerated in patients with refractory or relapsed and refractory multiple myeloma, and of comparable efficacy if moderate renal impairment is present. This trial was registered with clinicaltrials.gov identifier 01311687 and EudraCT identifier 2010-019820-30.",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Dexamethasone, Female, Follow-Up Studies, Humans, Kidney Function Tests, Male, Middle Aged, Multiple Myeloma, Renal Insufficiency, Retreatment, Survival Analysis, Thalidomide, Treatment Outcome, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",
author = "Weisel, {Katja C} and Dimopoulos, {Meletios A} and Philippe Moreau and Lacy, {Martha Q} and Song, {Kevin W} and Michel Delforge and Lionel Karlin and Hartmut Goldschmidt and Anne Banos and Albert Oriol and Adrian Alegre and Christine Chen and Michele Cavo and Laurent Garderet and Valentina Ivanova and Joaquin Martinez-Lopez and Stefan Knop and Xin Yu and Kevin Hong and Lars Sternas and Christian Jacques and Zaki, {Mohamed H} and {San Miguel}, Jesus",
note = "Copyright{\textcopyright} Ferrata Storti Foundation.",
year = "2016",
month = jul,
doi = "10.3324/haematol.2015.137083",
language = "English",
volume = "101",
pages = "872--8",
journal = "HAEMATOLOGICA",
issn = "0390-6078",
publisher = "Ferrata Storti Foundation",
number = "7",

}

RIS

TY - JOUR

T1 - Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma

AU - Weisel, Katja C

AU - Dimopoulos, Meletios A

AU - Moreau, Philippe

AU - Lacy, Martha Q

AU - Song, Kevin W

AU - Delforge, Michel

AU - Karlin, Lionel

AU - Goldschmidt, Hartmut

AU - Banos, Anne

AU - Oriol, Albert

AU - Alegre, Adrian

AU - Chen, Christine

AU - Cavo, Michele

AU - Garderet, Laurent

AU - Ivanova, Valentina

AU - Martinez-Lopez, Joaquin

AU - Knop, Stefan

AU - Yu, Xin

AU - Hong, Kevin

AU - Sternas, Lars

AU - Jacques, Christian

AU - Zaki, Mohamed H

AU - San Miguel, Jesus

N1 - Copyright© Ferrata Storti Foundation.

PY - 2016/7

Y1 - 2016/7

N2 - Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 - < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 - < 60 mL/min (P<0.001) and 4.0 versus 2.0 months in the group with baseline creatinine clearance ≥ 60 mL/min (P<0.001). Median overall survival for pomalidomide + low-dose dexamethasone versus high-dose dexamethasone was 10.4 versus 4.9 months (P=0.030) and 15.5 versus 9.2 months (P=0.133), respectively. Improved renal function, defined as an increase in creatinine clearance from < 60 to ≥ 60 mL/min, was similar in pomalidomide + low-dose dexamethasone and high-dose dexamethasone patients (42% and 47%, respectively). Improvement in progression-free and overall survival in these patients was comparable with that in patients without renal impairment. There was no increase in discontinuations of therapy, dose modifications, and adverse events in patients with moderate renal impairment. Pomalidomide at a starting dose of 4 mg + low-dose dexamethasone is well tolerated in patients with refractory or relapsed and refractory multiple myeloma, and of comparable efficacy if moderate renal impairment is present. This trial was registered with clinicaltrials.gov identifier 01311687 and EudraCT identifier 2010-019820-30.

AB - Pomalidomide + low-dose dexamethasone is effective and well tolerated for refractory or relapsed and refractory multiple myeloma after bortezomib and lenalidomide failure. The phase III trial MM-003 compared pomalidomide + low-dose dexamethasone with high-dose dexamethasone. This subanalysis grouped patients by baseline creatinine clearance ≥ 30 - < 60 mL/min (n=93, pomalidomide + low-dose dexamethasone; n=56, high-dose dexamethasone) or ≥ 60 mL/min (n=205, pomalidomide + low-dose dexamethasone; n=93, high-dose dexamethasone). Median progression-free survival was similar for both subgroups and favored pomalidomide + low-dose dexamethasone versus high-dose dexamethasone: 4.0 versus 1.9 months in the group with baseline creatinine clearance ≥ 30 - < 60 mL/min (P<0.001) and 4.0 versus 2.0 months in the group with baseline creatinine clearance ≥ 60 mL/min (P<0.001). Median overall survival for pomalidomide + low-dose dexamethasone versus high-dose dexamethasone was 10.4 versus 4.9 months (P=0.030) and 15.5 versus 9.2 months (P=0.133), respectively. Improved renal function, defined as an increase in creatinine clearance from < 60 to ≥ 60 mL/min, was similar in pomalidomide + low-dose dexamethasone and high-dose dexamethasone patients (42% and 47%, respectively). Improvement in progression-free and overall survival in these patients was comparable with that in patients without renal impairment. There was no increase in discontinuations of therapy, dose modifications, and adverse events in patients with moderate renal impairment. Pomalidomide at a starting dose of 4 mg + low-dose dexamethasone is well tolerated in patients with refractory or relapsed and refractory multiple myeloma, and of comparable efficacy if moderate renal impairment is present. This trial was registered with clinicaltrials.gov identifier 01311687 and EudraCT identifier 2010-019820-30.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Dexamethasone

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Kidney Function Tests

KW - Male

KW - Middle Aged

KW - Multiple Myeloma

KW - Renal Insufficiency

KW - Retreatment

KW - Survival Analysis

KW - Thalidomide

KW - Treatment Outcome

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Randomized Controlled Trial

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

U2 - 10.3324/haematol.2015.137083

DO - 10.3324/haematol.2015.137083

M3 - SCORING: Journal article

C2 - 27081177

VL - 101

SP - 872

EP - 878

JO - HAEMATOLOGICA

JF - HAEMATOLOGICA

SN - 0390-6078

IS - 7

ER -