DARZALEX® + Velcade® + thalidomide + dexamethasone (DVTd)
Transplant-eligible
DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib), thalidomide and dexamethasone*[1][2]
HIGHLIGHT
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)
Page contents
Efficacy
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]
Dosing
DARZALEX® + VTd dosing schedule: 4-week cycle regimen[1]
Treatment | Dose | 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 |
Thalidomide | 100 mg PO | Cycles 1–2: Once daily |
Dexamethasone | 40 mg IV/PO | Cycles 1–2: Twice weekly during Weeks 1–3 Cycles 3–4: Day 1 and 2 of each cycle |
Dexamethasone | 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
CASSIOPEIA study
Summary of study design, efficacy results and safety profile for DVTd in transplant-eligible NDMM.
Glossary
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
