DARZALEX® + Velcade® + melphalan + prednisone (DVMP)
Transplant-ineligible
DARZALEX® delivers remarkable efficacy in combination with Velcade® (bortezomib), melphalan and prednisone*[1][2][3][4]
ALCYONE study
Prof. María-Victoria Mateos presents the results from ALCYONE study.
Study design
ALCYONE is a randomised, open-label, active controlled, multicentre phase 3 study comparing DVMP vs. VMP alone. N=706[2]
* DVTd vs. VTd alone.
ALCYONE study profile
(PDF, 5.8 MB)
Page contents
Efficacy
ALCYONE: Updated analysis presented at the ASH Annual Meeting 2020
Median follow-up: 40.1 months[4]
Progression-free survival
Overall survival
Complete response or better
MRD negativity (10-5)†
Subgroup analyses
DARZALEX® + VMP provided consistently better responses regardless of age or cytogenetic risk.[4]
With increasing depth of response to DARZALEX® + VMP (≥CR with MRD negativity vs. ≥CR vs. VGPR vs. PR), patients achieved greater outcomes in progression-free survival, time to next therapy, overall survival, and health-related quality of life.[5]
Sustained MRD negativity
In both treatment arms of the ALCYONE study, MRD negativity sustained for a minimum of 12 months resulted in improved PFS and OS compared with MRD negativity sustained for less than 12 months.[4]
* DVMP vs. VMP alone.
† Minimal residual disease was assessed by means of an Adaptive Biotechnologies clonoSEQ next-generation sequencing assay (version 2.0) with the use of bone marrow aspirate collected at screening, at the time of confirmation of CR/sCR and at 12, 18, 24, and 30 months after the first dose.[2]
Safety Profile
DARZALEX® + VMP offers a manageable tolerability profile
- Consistent safety profile with known tolerability of regimen components[2]
- Lower discontinuation rates due to adverse events with DVMP vs. VMP[4]
- IRRs were usually Grade 1–2, and the majority occurred during the first infusion[2]
* DVMP vs. VMP alone.
Dosing
DARZALEX® + VMP dosing schedule: 6-week cycle regimen[1]
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) | 1800 mg SC | Cycle 1: Weekly Cycles 2–9: Every 3 weeks Cycles 10+: Every 4 weeks until disease progression |
Velcade® (bortezomib) | 1.3 mg/m2 SC | Cycle 1: Twice weekly on Weeks 1, 2, 4 and 5 Cycles 2–9: Once weekly on Weeks 1, 2, 4 and 5 |
Melphalan | 9 mg/m2 PO | Once daily on days 1–4 of each cycle until disease progression |
| Prednisone | 60 mg/m2 PO† | Once daily on days 1–4 of each cycle until disease progression |
DVMP 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
ALCYONE study
Summary of study design, efficacy results and safety profile for DVMP in transplant-ineligible NDMM.
Glossary
ASH: American Society of Hematology
CR: complete response
DVMP: DARZALEX®, Velcade®, melphalan, prednisone
IRR: infusion-related reaction
IV: intravenous
MRD: minimal residual disease
NDMM: newly-diagnosed multiple myeloma
PO: oral
PR: partial response
SC: subcutaneous
sCR: stringent complete response
VGPR: very good partial response
VMP: Velcade®, melphalan, prednisone
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
