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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

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

Para visualizar o IECRCM de Darzalex, veja aqui.

Referências

RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
Mateos MV et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018;378:518–528.
Dimopoulos MA et al. One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Patients (Pts) with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): Alcyone. Oral presentation at the 60th annual meeting of the American Society of Hematology (ASH). San Diego CA, December 1–4, 2018. #156.
Mateos MV et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. Lancet. 2019;395:132–141.
Rodriguez-Otero P et al. Long-term Outcomes and Health-related Quality of Life (HRQoL) by Response Status for Bortezomib, Melphalan, and Prednisone (VMP) ± Daratumumab (DARA) in ALCYONE. Poster presented at the 62nd American Society of Hematology (ASH) annual meeting; December 5–8, 2020. #3238.
CP-287814 - Março 2022