DARZALEX® + lenalidomide + dexamethasone (DRd)
After at least one prior therapy
DARZALEX® delivers remarkable efficacy in combination with lenalidomide and dexamethasone (Rd) in relapsed/refractory patients with ≥1 prior therapy*[1][2][3][4][5][6]
Highlight
Prof. María-Victoria Mateos presents 4-year follow-up data for DARZALEX® + Rd in relapsed/refractory multiple myeloma (POLLUX TRIAL)
Study design
POLLUX is a randomised, open-label, active-controlled, multicentre phase 3 study comparing DARZALEX® + Rd (DRd) vs. Rd. N=569[2]
* DVTd vs. VTd alone.
POLLUX study profile
(PDF, 5.8 MB)
Page contents
Efficacy
POLLUX: Updated analysis presented at the ASH Annual Meeting 2019
Median follow-up: 54.8 months[3]
Progression-free survival
Complete response or better
Progression-free survival
Subgroup analyses
DARZALEX® + Rd provided consistently better outcomes across pre-specified patient subgroups[2][3][5][6]
- High-risk cytogenetics
- Prior lenalidomide exposure
- One prior line of therapy
* DRd vs. Rd alone.
† MRD testing was performed on ficolled bone marrow aspirate samples via the clonoSEQ® assay V2.0 (Adaptive Biotechnologies, Seattle, WA) at a sensitivity threshold of 10-5 (1 cancer cell per 100,000 nucleated cells).[4]
Safety Profile
DARZALEX® + Rd offers a manageable tolerability profile
- Consistent safety profile with known tolerability of regimen components[2]
- Discontinuation rates were similar for DRd and Rd[3]
- IRRs were usually Grade 1–2, and the majority occurred during the first infusion[2]
- No new safety concerns were identified with longer follow-up (>4 years)[3]
* DRd vs. Rd alone.
Dosing
DARZALEX® + Rd dosing schedule: 4-week cycle regimen[1]
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) | 1800 mg SC | Cycle 1–2: Weekly Cycles 3–6: Every 3 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 PO/IV† | Every week until disease progression |
† On daratumumab infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.[1]
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
POLLUX study
Summary of study design, efficacy results and safety profile for DRd in RRMM.
Glossary
DRd: DARZALEX®, lenalidomide, dexamethasone
IRR: infusion-related reaction
IV: intravenous
MRD: minimal residual disease
NR: not reached
PO: oral
Rd: lenalidomide, dexamethasone
RRMM: relapsed/refractory multiple myeloma
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
