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Clinical Trial
. 2017 May;177(3):404-413.
doi: 10.1111/bjh.14549. Epub 2017 Feb 17.

Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study

Meletios A Dimopoulos  1 , A Keith Stewart  2 , Tamás Masszi  3 , Ivan Špička  4 , Albert Oriol  5 , Roman Hájek  6 , Laura Rosiñol  7 , David Siegel  8 , Georgi G Mihaylov  9 , Vesselina Goranova-Marinova  10 , Péter Rajnics  11 , Aleksandr Suvorov  12 , Ruben Niesvizky  13 , Andrzej Jakubowiak  14 , Jesus San-Miguel  15 , Heinz Ludwig  16 , Antonio Palumbo  17 , Mihaela Obreja  18 , Sanjay Aggarwal  18 , Philippe Moreau  19
Affiliations
Clinical Trial

Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study

Meletios A Dimopoulos et al. Br J Haematol. 2017 May.

Abstract

A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old. Median PFS for patients <70 years old was 28·6 months for the carfilzomib group versus 17·6 months for the control group [hazard ratio (HR), 0·701]. Median PFS for patients ≥70 years old was 23·8 months for the carfilzomib group versus 16·0 months for the control group (HR, 0·753). For patients <70 years the overall response rate (ORR) was 86·0% (carfilzomib group) and 66·9% (control group); for patients ≥70 years old the ORR was 90·3% (carfilzomib group) and 66·1% (control group). Within the carfilzomib group, grade ≥3 cardiovascular adverse events occurred more frequently among patients ≥70 years old compared with patients <70 years old. Carfilzomib-lenalidomide-dexamethasone has a favourable benefit-risk profile for patients with RMM, including elderly patients ≥70 years old.

Trial registration: clinicaltrials.gov identifier: NCT01080391.

Keywords: carfilzomib; clinical trial; dexamethasone; lenalidomide; relapsed multiple myeloma.

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Figures

Figure 1
Figure 1
Kaplan–Meier PFS Curves for (A) <70 years of Age Subgroup and (B) ≥70 years of Age Subgroup. CI, confidence interval; HR, hazard ratio; KRd, carfilzomib‐lenalidomide‐dexamethasone; mo, months; PFS, progression‐free survival; Rd, lenalidomide‐dexamethasone
Figure 2
Figure 2
HRQOL for (A) <70 years of Age Subgroup and (B) ≥70 years of Age Subgroup. Mean scores (reported as change from baseline) from the EORTC QLQ‐C30 scale and standard errors are shown. Higher scores denote better quality of life. HRQOL, health‐related quality of life; KRd, carfilzomib‐lenalidomide‐dexamethasone; Rd, lenalidomide‐dexamethasone.
See this image and copyright information in PMC

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