DARZALEX® + Velcade® + dexamethasone (DVd)
After at least one prior therapy
DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib) and dexamethasone (Vd) in relapsed/refractory patients with ≥1 prior therapy*[1][2][3][4]
Highlight
Prof. María-Victoria Mateos discusses 4-year updates on the CASTOR study – DARZALEX®+ Vd in RRMM
Study design
CASTOR is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DARZALEX® + Vd (DVd) vs. Vd. N=498[2]
* DVTd vs. VTd alone.
CASTOR study profile
(PDF, 5.8 MB)
Page contents
Efficacy
CASTOR: Updated analysis presented at the ASH Annual Meeting 2019
Median follow-up: 50.2 months[4]
Progression-free survival
Complete response or better
MRD negativity (10-5)†
Subgroup analyses
DARZALEX® + Vd provided consistently better outcomes across pre-specified patient subgroups:[3][4][5][6]
- High-risk cytogenetics
- Prior lenalidomide exposure
- One prior line
* DVd vs. Vd alone.
† MRD was assessed via next-generation sequencing on bone marrow aspirate samples that were ficolled and evaluated by the US Food and Drug Administration–approved clonoSEQ® assay V2.0 (Adaptive Biotechnologies, Seattle, WA) at sensitivity thresholds of 10-4 (1 cancer cell per 10,000 nucleated cells), 10-5, and 10-6.[3]
Safety Profile
DARZALEX® + Vd offers a manageable tolerability profile
- No new safety concerns with longer follow-up (>4 years)[4]
- Similar discontinuation rates between DVd and Vd[4]
- Manageable infusion-related reactions (IRRs), with the majority occurring during the first infusion[2]
* DRd vs. Vd alone.
Dosing
DARZALEX® + Vd dosing schedule: 3-week cycle regimen[1]
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) | 1800 mg SC | Cycle 1–3: Weekly Cycles 4–8: Every 3 weeks Cycles 9+: Every 4 weeks until disease progression |
Velcade® (bortezomib) | 1.3 mg/m2 SC/IV | Cycles 1–8: Twice weekly on Weeks 1 and 2 |
Dexamethasone | 20 mg PO† | Cycles 1–8: Days 1, 2, 4, 5, 8, 9, 11 and 12 |
† On DARZALEX® dosing days, the pre-administration medication replaces the daily dose of dexamethasone.
DVd 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
CASTOR study
Summary of study design, efficacy results and safety profile for DVd in RRMM.
Glossary
ASH: American Society of Hematology
DVd: DARZALEX®, Velcade®, dexamethasone
IRR: infusion-related reaction
IV: intravenous
MRD: minimal residual disease
PO: orally
RRMM: relapsed/refractory multiple myeloma
SC: subcutaneous
Vd: Velcade®, 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
