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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)

Efficacy

ALCYONE: Updated analysis presented at the ASH Annual Meeting 2020

Median follow-up: 40.1 months[4]

Progression-free survival

MRD-negativity-28pc@1x

Overall survival

Overall-survival-40pc@1x.png

Complete response or better

complete-response-46pc@1x.png

MRD negativity (10-5)†

MRD-negativity-28pc@1x.png
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

thumbnail-DVMP-dosing-schedule@1x.jpg

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

Para visualizar o IECRCM de Darzalex, veja aqui.
CP-287814 - março 2022