DARZALEX® + Velcade® + thalidomide + dexamethasone (DVTd)


DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib), thalidomide and dexamethasone*[1][2]


Prof. Philippe Moreau presents the latest data from the CASSIOPEIA study – DARZALEX® + VTd in transplant-eligible NDMM

Study design

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[1][2]

* DVTd vs. VTd alone.

CASSIOPEIA study profile

(PDF, x.x MB)


CASSIOPEIA: Primary and final analysis of part 1 of the study

Median follow-up: 18.8 months[2]

MRD negativity (10-5)

Stringent complete response (sCR)

Progression-free survival

Subgroup analyses

DARZALEX® + VTd provided consistently high efficacy across pre-specified patient subgroups[2][3]

  • Consistent rate of sCR across most predefined subgroups[2]
  • Consistent MRD benefit across predefined subgroups including ISS III and high-risk cytogenetics[2][3]
  • PFS benefit maintained across predefined subgroups[2]

* DVTd vs. VTd alone.
† At 10-5 sensitivity threshold compared with VTd alone (p<0.0001).
‡ Assessed 100 days after ASCT.

Safety Profile

DARZALEX® + VTd offers a predictable and manageable tolerability profile[2]
  • Consistent safety profile with known tolerability of regimen components[2]
  • Similar discontinuation rates due to TEAEs for DVTd vs. VTd[2]
  • IRRs were usually Grade 1–2, and the vast majority occurred during the first infusion[2]


DARZALEX® + VTd dosing schedule: 4-week cycle regimen[1]



Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycle 1–2: Weekly

Cycles 3–4: Every 2 weeks

During ASCT: None

Cycles 5–6: Every 2 weeks

Velcade® (bortezomib)

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)

Quick downloads

SC Checklist beginning of treatment

Includes a first use checklist of Darzalex® SC.

Darzalex® SC Practical Guide

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

IV: intravenous

MM: multiple myeloma

MRD: minimal residual disease

NDMM: newly-diagnosed multiple myeloma

PFS: progression-free survival

PO: oral

SC: subcutaneous

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

CP-287814 - March 2022