Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma

ASPIRE Investigators

Research output: Article

613 Citations (Scopus)

Abstract

Background Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. Methods We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Results Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P = 0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P = 0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P

Original languageEnglish
Pages (from-to)142-152
Number of pages11
JournalNew England Journal of Medicine
Volume372
Issue number2
DOIs
Publication statusPublished - jan. 8 2015

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Multiple Myeloma
Dexamethasone
Control Groups
Disease-Free Survival
Confidence Intervals
Proteasome Inhibitors
carfilzomib
lenalidomide
Survival Rate
Survival

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. / ASPIRE Investigators.

In: New England Journal of Medicine, Vol. 372, No. 2, 08.01.2015, p. 142-152.

Research output: Article

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abstract = "Background Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. Methods We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Results Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95{\%} confidence interval [CI], 0.57 to 0.83; P = 0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3{\%} and 65.0{\%} in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95{\%} CI, 0.63 to 0.99; P = 0.04). The rates of overall response (partial response or better) were 87.1{\%} and 66.7{\%} in the carfilzomib and control groups, respectively (P",
author = "{ASPIRE Investigators} and Stewart, {A. Keith} and Rajkumar, {S. Vincent} and Dimopoulos, {Meletios A.} and T. Masszi and Ivan Špicka and Albert Oriol and Roman Hajek and Laura Rosinol and Siegel, {David S.} and Mihaylov, {Georgi G.} and Vesselina Goranova-Marinova and Peter Rajnics and Aleksandr Suvorov and Ruben Niesvizky and Jakubowiak, {Andrzej J.} and San-Miguel, {Jesus F.} and Heinz Ludwig and Michael Wang and Vladimir Maisnar and Jiri Minarik and Bensinger, {William I.} and Mateos, {Maria Victoria} and Dina Ben-Yehuda and Vishal Kukreti and Naseem Zojwalla and Tonda, {Margaret E.} and Xinqun Yang and Biao Xing and Philippe Moreau and Antonio Palumbo",
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T1 - Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma

AU - ASPIRE Investigators

AU - Stewart, A. Keith

AU - Rajkumar, S. Vincent

AU - Dimopoulos, Meletios A.

AU - Masszi, T.

AU - Špicka, Ivan

AU - Oriol, Albert

AU - Hajek, Roman

AU - Rosinol, Laura

AU - Siegel, David S.

AU - Mihaylov, Georgi G.

AU - Goranova-Marinova, Vesselina

AU - Rajnics, Peter

AU - Suvorov, Aleksandr

AU - Niesvizky, Ruben

AU - Jakubowiak, Andrzej J.

AU - San-Miguel, Jesus F.

AU - Ludwig, Heinz

AU - Wang, Michael

AU - Maisnar, Vladimir

AU - Minarik, Jiri

AU - Bensinger, William I.

AU - Mateos, Maria Victoria

AU - Ben-Yehuda, Dina

AU - Kukreti, Vishal

AU - Zojwalla, Naseem

AU - Tonda, Margaret E.

AU - Yang, Xinqun

AU - Xing, Biao

AU - Moreau, Philippe

AU - Palumbo, Antonio

PY - 2015/1/8

Y1 - 2015/1/8

N2 - Background Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. Methods We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Results Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P = 0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P = 0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P

AB - Background Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. Methods We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Results Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P = 0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P = 0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P

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U2 - 10.1056/NEJMoa1411321

DO - 10.1056/NEJMoa1411321

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