Written in Blood
higher rates of PFS at
TABLE. Treatment Responses
two years compared with
Carfilzomib Group
Bortezomib Group
Odds Ratio
MRD-positive patients, ir-
(n=478)
(n=477)
(95% CI; p Value)
respective of treatment re-
Best Response
ceived, the authors noted.
Stringent complete response, n (%)
13 (2.7)
10 (2.1)
“Identical MRD-negative
Complete response, n (%)
111 (23.2)
100 (21.0)
rates between treatment
Very good partial response, n (%)
169 (35.4)
125 (26.2)
arms anticipated the lack
Partial
response,
n
(%)
110
(23.0)
141 (29.6)
N/A
of significant differences
in PFS between arms,
Stable disease, n (%)
50 (10.5)
75 (15.7)
demonstrating the poten-
Progressive disease, n (%)
3 (0.6)
3 (0.6)
tial role of MRD as a sur-
Not evaluable, n (%)
22 (4.6)
23 (4.8)
rogate endpoint in clinical
Complete response or better, % (95% CI)
25.9 (22.1-30.1)
23.1 (19.4-27.1)
1.179 (0.875-1.589; p=0.14)
trials,” they added.
Overall response rate, % (95% CI)
84.3 (80.7-87.5)
78.8 (74.9-82.4)
1.412 (1.010-1.973; p=0.02)
The incidence of grade
≥3 adverse events (AEs)
was 74.7 percent and 76.2
• peripheral edema
percent. Grade ≥3 AEs
drug to combine with carfilzomib in this set-
that were at least 5-percent more frequent
ting,” the researchers concluded. “Alternative
• dyspnea
in KMP-treated patients than VMP-treated
carfilzomib-based regimens merit further
patients included:
evaluation in [patients with newly diagnosed
• chills
MM].”
• anemia
The study’s findings are limited by
In addition, the incidence of AEs leading
the fixed treatment duration used in the
to treatment discontinuation (16.7% and
• pyrexia
CLARION protocol, as well as by its open-
14.7%), serious AEs (49.6% and 42.1%), and
label design, which may have introduced bias.
treatment-emergent, grade 5 AEs (6.5% and
• nausea
The authors report relationships with
4.3%) was higher with carfilzomib than with
Amgen, which sponsored the study. ●
bortezomib.
• vomiting
REFERENCE
“Increased toxicity in the carfilzomib
Facon T, Lee JH, Moreau P, et al. Randomized phase 3 study of carfilzomib or
group of CLARION may explain clinical
• hypertension
bortezomib with melphalan-prednisone for transplant-ineligible, NDMM pa-
outcomes, and melphalan may not be an ideal
tients. Blood. 2019 February 28. [Epub ahead of print]
Save the Date!
61st ASH
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Orlando, Florida • December 7-10, 2019
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ASH Clinical News
1/16/19 4:58 PM
April 2019