DARZALEX ® + Vd significantly improved PFS vs Vd alone 1
100
61
%
80
60
61
40
DARZALEX ® + Vd
Vd
20
P<0.0001
HR=0.39 (95% CI: 0.28, 0.53)
0
0
3
6
9
12
15
reduction in the risk of
disease progression or
death with DARZALEX ® + Vd
%
CASTOR was an open-label, randomized,
active-controlled phase 3 trial comparing
with DARZALEX ® 16 mg/kg + Vd
reduction treatment
in the
(n=251) to Vd alone (n=247) in multiple
risk of disease
myeloma
patients who received a minimum of
progression
or
death with
1 prior therapy. Patients receiving DARZALEX ®
®
+ Vd
DARZALEX were
treated with pre- and post-infusion
medications. DARZALEX ® was given until
disease progression. Efficacy was evaluated
by PFS based on International Myeloma
Working Group (IMWG) criteria. 1,2
Months
79.3
%
ORR with DARZALEX ® + Vd vs 59.9% with Vd alone (P<0.0001). CR or better was 18.3% with DARZALEX ® + Vd vs 8.5%
with Vd alone. VGPR was 38.2% vs 19.0%, and PR was 22.7% vs 32.4% with DARZALEX ® + Vd vs Vd alone, respectively. 1
Vd=bortezomib and dexamethasone.
DRUG INTERACTIONS
Important Safety Information (cont’d)
Interference with Determination of Complete Response
Daratumumab is a human IgG kappa monoclonal antibody that
can be detected on both the serum protein electrophoresis (SPE)
and immunofixation (IFE) assays used for the clinical monitoring
of endogenous M-protein. This interference can impact the
determination of complete response and of disease progression
in some patients with IgG kappa myeloma protein.
Adverse Reactions
In patients who received DARZALEX ® in combination with
lenalidomide and dexamethasone, the most frequently reported
adverse reactions (incidence ≥20%) were: neutropenia (92%),
thrombocytopenia (73%), upper respiratory tract infection (65%),
infusion reactions (48%), diarrhea (43%), fatigue (35%), cough
(30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and
pyrexia (20%). The overall incidence of serious adverse reactions
was 49%. Serious adverse reactions were pneumonia (12%), upper
respiratory tract infection (7%), influenza (3%) and pyrexia (3%).
Effect of Other Drugs on Daratumumab: The coadministration of
lenalidomide or bortezomib with DARZALEX ® did not affect the
pharmacokinetics of daratumumab.
Effect of Daratumumab on Other Drugs: The coadministration of
DARZALEX ® with bortezomib did not affect the pharmacokinetics
of bortezomib.
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