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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

Overall survival

Complete response or better

MRD negativity (10-5)†

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

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.

Glossary

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

Para visualizar o IECRCM de Darzalex, veja aqui.

Referências

Facon T, et al. Overall survival results with daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study. Abstract presented at the EHA2021 Virtual Congress; June 9–17, 2021. #LB1901.
Kumar SK, et al. Updated Analysis of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): The Phase 3 Maia Study. Poster presented at the 62nd American Society of Hematology (ASH) annual meeting; December 5–8, 2020. #2276.
Facon T, et al. Daratumumab plus Lenalidomideand Dexamethasone for Untreated Myeloma. N Engl J Med. 2019;380:2104–2115.
RCM DARZALEX ®. Acedido em março de 2022. Disponível em www.ema.europa.eu
CP-287814 - Março 2022