DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib), thalidomide and dexamethasone*
Prof. Philippe Moreau presents the latest data from the CASSIOPEIA study – DARZALEX® + VTd in transplant-eligible NDMM
CASSIOPEIA is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DVTd with VTd alone in newly-diagnosed ASCT-eligible patients with MM. N=1,085
* DVTd vs. VTd alone.
(PDF, x.x MB)
CASSIOPEIA: Primary and final analysis of part 1 of the study
DARZALEX® + VTd provided consistently high efficacy across pre-specified patient subgroups
* DVTd vs. VTd alone.
† At 10-5 sensitivity threshold compared with VTd alone (p<0.0001).
‡ Assessed 100 days after ASCT.
1800 mg SC
Cycle 1–2: Weekly
Cycles 3–4: Every 2 weeks
During ASCT: None
Cycles 5–6: Every 2 weeks
1.3 mg/m2 SC/IV
Cycles 1–6: Twice weekly during Weeks 1 and 2
100 mg PO
Cycles 1–2: Once daily
40 mg IV/PO
Cycles 1–2: Twice weekly during Weeks 1–3
Cycles 3–4: Day 1 and 2 of each cycle
20 mg IV/PO
Cycles 3–4: Twice weekly during Weeks 2 and 3
Cycles 5–6: Twice weekly during Weeks 1–3
DVTd dosing schedule
(PDF, xx KB)
Includes a first use checklist of Darzalex® SC.
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
Summary of study design, efficacy results and safety profile for DVTd in transplant-eligible NDMM.
ASCT: autologous stem cell transplantation
DVTd: DARZALEX®, Velcade®, thalidomide, dexamethasone
IRR: infusion-related reaction
MM: multiple myeloma
MRD: minimal residual disease
NDMM: newly-diagnosed multiple myeloma
PFS: progression-free survival
sCR: stringent complete response
TEAE: treatment-emergent adverse event
VTd: Velcade®, thalidomide, dexamethasone
Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.
Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.
Antes de prescrever consulte o RCM completo.
RCM de Darzalex®, veja aqui