DARZALEX® + lenalidomide + dexamethasone (DRd)

Transplant-ineligible

DARZALEX® delivers remarkable efficacy in combination with lenalidomide and dexamethasone*[1]

Highlight — 2020 update

Thierry Facon, of Lille University Hospital, dicusses the first results from MAIA study.

Study design

MAIA is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DRd with Rd alone in newly-diagnosed transplant-ineligible patients with MM. N=737[2]

* DVTd vs. VTd alone.

MAIA study profile

(PDF, 5.8 MB)

Efficacy

NEW DATA | MAIA: Updated analysis presented at the EHA 2021[1]

Median follow-up: 56.2 months[1]

Progression-free survival

progression-free-survival-47pc@1x

Overall survival

risk-of-death-32pc@1x.png

Complete response or better

complete-response-51pc@1x

MRD negativity (10-5)†

MRD-negativity-31pc@1x.png
Further efficacy results[1]
  • DARZALEX® + Rd provided generally consistent OS benefit across pre-specified patient subgroups[1]
  • The progression-free survival and overall survival benefits were maintained among the 44% of patients who were ≥75 years of age[1]
  • MRD-negative patients experienced longer progression-free survival compared with those who were MRD positive[2]

* DRd vs. Rd alone.
†At 10-5 sensitivity threshold compared with Rd alone (p<0.0001).
ǂ Follow-up at 47.9 months

Safety Profile

DARZALEX® + Rd offers a predictable and manageable tolerability profile despite the elderly population[1]
  • 44% of patients in the study were aged ≥75 years[1]
  • No new safety concerns occurred even with almost five years of continuous therapy and follow-up[1]
  • Lower discontinuation rates due to AEs for DRd vs. Rd[1]
  • IRRs were usually Grade 1–2, and the vast majority occurred during the first infusion[3]

* DRd vs. Rd alone.

Dosing

DARZALEX® + Rd dosing schedule: 4-week cycle regimen[4]

Treatment

Dose

Dosing schedule

DARZALEX® (daratumumab)

1800 mg SC

Cycle 1–2: Weekly

Cycles 3–4: Every 2 weeks

Cycles 7+: Every 4 weeks until disease progression

Lenalidomide

25 mg PO

Once daily on Days 1–21 of each cycle until disease progression

Dexamethasone

40 mg IV/PO

Once weekly or a reduced dose of 20 mg/m2 week for patients >75 years or BMI <18.5 kg/m2

dosing-schedule-DVTd@1x

DRd 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

MAIA study

Summary of study design, efficacy results and safety profile for DRd in transplant-ineligible NDMM.

AE: adverse event

ASH: American Society of Hematology

DRd: DARZALEX®, lenalidomide, dexamethasone

IRR: infusion-related reaction

IV: intravenous

MM: multiple myeloma

MRD: minimal residual disease

NDMM: newly-diagnosed multiple myeloma

PO: oral

Rd: lenalidomide, dexamethasone

SC: subcutaneous

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