DARZALEX® delivers remarkable efficacy in combination with lenalidomide and dexamethasone*[1]
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.
(PDF, 5.8 MB)
NEW DATA | MAIA: Updated analysis presented at the EHA 2021[1]
* DRd vs. Rd alone.
†At 10-5 sensitivity threshold compared with Rd alone (p<0.0001).
ǂ Follow-up at 47.9 months
* DRd vs. Rd alone.
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)
Includes a first use checklist of Darzalex® SC.
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
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